Regulatory Affairs: Assist in preparation for FDA meetings: pre-IND, end-of-phase 2, pre-NDA/BLA, etc. He followed his PhD with a Post-Doctoral Fellowship (Bone Metastasis Pain) in the department of Pathology & Molecular Medicine. He has been teaching at the post-secondary level since 2006, and with McMaster since 2008. in Biochemistry from The Ohio State university in 2017 and obtained his M.S. Meet our expert team of best-in-class instructors who teach hands-on, real-world skills and knowledge gained through years of industry experience. Catherine Howson is an instructor in the Addiction Education Program at McMaster University. (2018) forecasted the likelihood of damage inducing earthquakes in both space and time using a hybrid physical-statistical model, which involved the evaluation of pore pressure change by a regional hydrogeologic model, and analysis of spatial variability of the seismogenic state. Pedram has worked in telecommunications in Iran (Ministry of Information and Technology) and Canada (Bell Canada) as a Voice and VOIP Specialist Manager. Ernesto is the founder of Kamaleidos Change Solutions, a consulting business focused on people change management in organizations. Ms. Reich completed a MS in biotechnology and regulatory affairs at Johns Hopkins University in 2007 and achieved her Regulatory Affairs Certification (RAC) in 2010. Her doctoral research focused on organizational culture and change. Mark Peco is a seasoned educator, consultant and team builder with expertise in data management, analytics and process improvement. This is her first year teaching at McMaster. (2). She also assisted with content compilation and Word formatting of Type B meeting requests and briefing packages, as well as orphan drug designations and annual reports. Both critical fluid pressure change and fracture criticality are higher for induced seismicity close to the injection wells and lower for those away from the wells. She has worked in diverse industries with executive leaders and employees to develop and implement effective total reward strategies. Richard has more than 25 years of experience working in Information Technology, with the last 20 years in the Canadian higher education sector. Invest in what you are passionate for or care about. His procedures are currently in use for commercial production or testing of lentiviral vectors in multiple regions. Over the course of her career, Karen Ann has worked in various health care settings, in a variety of roles. He has more than 35 years of experiences in a varied industries and has taught at McMaster since 1992. He holds multiple certifications through the Association of Canadian Mountain Guides and enjoys spending as much time wandering through the hills as possible. Vijay Jethwa, PhD joined Biologics Consulting as a Senior Consultant (Analytical/CMC) in 2013. Diane is an independent healthcare strategist and quality improvement consultant with over 20 years of health sector experience. She is pursuing her academic ambition to be an academic lecturer in sustainability within global universities and continue her consulting and entrepreneurship activities within the global markets. Vans unique ability to foster connection and learning extends beyond the therapeutic relationship. %%EOF Joseph has 33 jobs listed on their profile. Prior to this role, Jonathan established and lead MLSEs Business Intelligence Centre of Excellence, which includes analytics, database marketing, and digital marketing (social, mobile, web), where he worked with senior leadership to apply data analytics across the business; and develop omni-channel marketing strategies for data acquisition, customer engagement, and revenue generation. Keith McIntyre is the CEO and owner of the KMAC Group and BLUEPRINCE Consulting. Dr. Dimas practical experience ranges from managing daily financial operations to handling a large portfolio of forward contracts and options; from managing and developing foreign subsidiaries to recording and implementing mergers and private acquisitions; from private firms to not-for-profit organizations; from European to North American Accounting Information Systems. Fault zones tend to be characterised by larger fracture criticality values than off-fault zones. Alison Foo specializes in clinical data management, clinical monitoring, stakeholder management and trial management. The forecasted seismically active regions extend from the ground surface to below 3km depth, but are characterised by the inverted cone shape. A strategic thinker, passionate leader of change and an effective communicator and facilitator, she excels in fast paced and changing work environments and in addition to building and maintaining strong relationships, she has broad coaching and leadership experience both corporately as well as in a wide array of charitable and community organizations. Kimberly has a Masters of Arts Degree in Leadership and People Strategy from the University of Guelph and obtained her HR Management Certificate from Seneca College. Edward has taught forensic accounting and accounting courses at various Universitys across Canada, and abroad, since 2007. She currently works in Clinical Operations at a global CRO. Rosie is a Certified Clinical Research Professional (CCRP) with the Society of Clinical Research Associates (SOCRA) and has presented at several of their research conferences and education forums. Eric is also an avid amateur photographer. He is experienced in the process of publishing, validation, submission and life-cycling of regulatory documents in eCTD format. They trained us effectively and made us feel capable and strong in engaging with the FDA., "Biologics has SMEs who are able to handle my requests., Our consultants feedback was tough, yet effective and the FDA does not question documents she has helped us prepare for submission., communication was easythey responded quickly to the queries we had during the preparation of the IND. She has a BScH from Queens University, a MSc from the University of Toronto, and is PMP certified from the Project Management Institute. Her dissertation, Returning to Cognitive Consonance: The Revolution of Self in Seventeenth-Century England, examines how, during the Spatial Reformation, varying concepts of space impacted individual identity, self-determination, and free will. She believes in the importance of educating in all areas of work and life, empowering folks to recognize their potential as a leader and peer. Their advice was accurate and helpful., they are a great, complementary team and enabler for our regulatory success. a multi-yearequity and inclusion audit of a large urban in Teaching from McMaster University; and a Doctorate in Education (Ed.D.) The gridblock dimension of the model is 100m in all the three directions. Royal and Athabasca Universities. Vidhya received her B.A. Dr. Anna Tubina is an instructor in Health and Wellness Coaching program at McMaster University. Whilst F1, F2 and F3 fault zones evolved seismotectonically from an active state during the first two half-year periods to a much suppressed state during the last two half-year periods, the seismotectonic state of F4 and F5 fault zones and off-fault zones maintained fairly low levels throughout. She is currently working towards her PhD in Work and Organizational Studies at the University of Sydney Business School, with a focus on the platform economy, gender roles and gender equality. Academic Essay Writing, RCM 103 - Retirement Community Management, SCC 102 - Therapeutic Applications of Cannabis, MKT 101 - Marketing Plans & Implementation, HIF 102 - Information Governance, Finance and Research, ESS 813 - Personal Leadership: Building From Our Strength, ESS 912 - Your Energy Currency: Enhancing and Improving Your Emotional Self-Awareness, PMP 401 - Project Management Fundamentals, PMP 402 - Leadership and Communications in Project Management, HTH 121 - Health Data Standards & Classifications, ACC 929 - Intermediate Management Accounting, BUS 860 - Foundations of Business Finance, ACR 101 - Principles of Clinical Research, ESS 834 - Giving & Receiving Constructive Feedback, https://www.linkedin.com/in/christineccosta, DMK 103 - Search Engine Optimization, Search Engine Marketing, & Digital Advertising, DAT 305 - Capstone Project Big Data Programming and Architecture, HTH 100 - Understanding the Canadian Health care System, DAT 104 - Data Analysis and Visualization, GLF 108 - Golf Course Design & Construction - Turf Management, PMP 403 - Technical Implementation in Project Management, HTH 101 - Health Information Management I, SKL 501 - Analyzing and Visualizing Data with Microsoft Excel, RSK 713 - Risk Management Principles & Practices, DAT 103 - Business Intelligence & Data Analytics, ESS 811 - Leadership Foundations - Focus on the 3 C'S, ESS 906 - How to Pick Up the Pieces - Leadership, Motivation and Gratitude in Action, ESS 907 - Effective Prioritization to Improve Decision Making, Manage Workload and Improve Well-being, ESS 913 - Flexible Work as a Catalyst for Organizational Agility & Well-being, DAT 105 - Artificial Intelligence (AI) for Business: An Introduction, HWC 200 - Behaviour Change for Health and Wellness, MND 101 - The Origins and Philosophies of Mindfulness, MND 102 - The Neuroscience and Science of Mindfulness, OSI 104 - Data Mining and Analysis Essentials, RCM 101 - Healthy Aging: Health, Wellness and Nutrition, ESS 805 - Unconscious Bias: How We Make Decisions, ESS 908 - Unconscious Bias: Moving from Bystander to Advocate, ACC 928 - Introductory Management Accounting, DAT 100 - Foundations of Computer Programming, GLF 107 - Retail Management for Golf Operations, SKL 101 - Fundamental Career Development Tools, MKT 103 - Integrated Marketing Communication, SUS 103 - Practices for Sustainable Business, SUS 104 - Responsible Production and Consumption, DAT 301 - Machine Learning for Big Data Analytics, ACC 927 - Intermediate Financial Accounting II, MKT 108 - Social Media Strategy & Management, DAT 200 - Statistical Analysis for Data Science, CCD 102 - Critical Thinking for Problem Solving, HTH 103 - Professionalism, Ethics & Professional Standards, ADD 206 - Assessment and Treatment Planning, ADD 204 - Addiction Treatment: Theories, Models and Applications for Professional Practice, SUS 102 - Practices for Sustainable Living, ADD 203 - Counselling Skills for Addiction Professionals, NRS 101 - Nursing Concepts in Continence Care, NRS 102 - Advanced Concepts in Continence Care, NRS 103 - Concepts in Continence Care Clinical Placement, ESS 904 - Influencing Others with Confidence and Success, ACC 925 - Introductory Financial Accounting, HDA 102 - Statistics Analysis for Health Data, ESS 874 - Finance For Non-Financial Managers, ADD 209 - Trauma Informed Care in Addiction, HTH 501 - Fundamentals of Health Research Methodology, BUS 847 - Principles & Practice of Supervision, PMI Agile Hybrid Project Pro Micro-Credential (AH-MC) 2020, PMI Agile Certified Practitioner (PMI-ACP) 2020, PMI Portfolio Management Professional (PfMP) 2017, PMI Program Management Professional (PgMP) 2015, PMI Project Management Professional (PMP) 2010, Management of Portfolio Foundation & Practitioner (MoP-P) 2019, Microsoft Certified Educator Technology Literacy for Educators: 21 Century Learning Design 2021, Microsoft Certified Professional Specialist (MCP) 2016, Information Technology Infrastructure Library v3 (ITIL V3) 2008. Kimberly is passionate about building sustainable, long-term growth through world-class HR practices. In: Earthquake prediction. In this research, fracture criticality, defined as the gradient of critical fluid pressure change to trigger seismicity (pc/h), is proposed as a novel reservoir depth-independent metric of fault slip susceptibility. Ms. Shirwa received her B.S. Her research work focuses on electronic medical record adoption and use, end-user support, and quality improvement. The seismicity recorded during the modelling period may be due to thermal effects from the previous decade of fluid injection, in addition to the direct pore pressure effect. Cambridge, MA and Tokyo Henry was responsible to assessing the technology strategies of both corporate and public sectors in Japan on behalf of the Program's 18 US-based corporate sponsors. Her work experience at companies like Maple Leaf Sports and Entertainment, Pelmorex Media and Panoff Publishing Inc. gave her the opportunity to work on beloved brands like The Toronto Maple Leafs, Toronto Raptors, Toronto FC, Coca-Cola, Molson, The Weather Network, Carnival Cruise Lines and Royal Caribbean Cruise Lines just to name a few. Lisa Gulesserian is a Learning and Development professional with a focus on leadership, career and women at work. Hes most passionate about non-linear dimension reduction methods. He lectures to the MBA programs of Queens and Ryerson Universities on the topics of Venture Finance, Innovation, Strategy, Entrepreneurship and Marketing, and has taught courses at McMaster since2014. Rita serves as the US Agent Representative for the sponsors. She entered management as the Branch Chief for orthopedic, physical medicine and anesthesiology devices in the Office of Compliance. She is a proud graduate of McMaster University and holds a Post-Graduate Certificate in Corporate Communications. Andrew brings over 17 years of sales, marketing, product management, and business development leadership for growth phase technology companies where he focuses on developing and executing product and marketing strategies from product-market-fit, to steady, scalable, revenue. Kathryn has worked with innovative teams throughout her career, been awarded team accolades for innovation and was humbled to receive personal career awards. She went on to become the Deputy Division Director for Cardiovascular Devices, and then served as director of the Office of Device Evaluation from 2004-2010. Peter MacDonaldis an Employment Development Consultant for the City of Hamilton, Department of Emergency and Community Services. She is familiar with FDA regulations and guidance, as well as policies and procedures at CBER, CDER, and OOPD. My career has included various roles in both Accounting and Payroll. He was instrumental in the design and startup of the companys 15,000 L scale manufacturing facilities in RTP, NC and Hillerod, Denmark. This evaluation framework is demonstrated using induced seismicity data recorded during a 2-year fluid re-injection period (15 April 202015 April 2022) at the Hellisheii geothermal field, Iceland. 0 She also supervised the cGMP Cell Banking suite before moving into technology transfer / process development group. This evaluation process, besides the comparison between recorded seismicity and probability forecasts, is iterated for each period until the end of fluid injection operations. Additionally, she has contributed to a variety of educational activities, including teaching graduate-level courses. OnePetro, Frolova J, Franzson H, Ladygin V et al (2004) Porosity and permeability of hyaloclastites tuffs, Iceland. In comparison, the seismotectonic state is conventionally represented by the seismogenic index , given by \(\Sigma =a+{\text{log}}_{10}(\frac{{N}_{\text{f}}}{S\cdot {p}_{\text{c},\text{max}}})\), where \(a={\text{log}}_{10}({N}_{{M}_{\text{L}}\ge 0})\) is a seismotectonic constant in the Gutenberg-Richter scaling law, Nf is the concentration of fractures, S is the poroelastic uniaxial storage coefficient, and pc,max is the maximum value of rock criticality (Shapiro et al. Christine consults with and develops programs and tools to support university staff through change, improving team effectiveness and managing talent. As the account manager, Becky was the liaison between the regulatory and quality departments and the IT department. Issued March 30, 2021 62 Whittemore Avenue Cambridge, MA 02140 (617) 876-1400 www.gcpat.com Manufacturing Plants: Bedford Park, IL Evanston, IL Mt. with distinction (strategic focus) and a DBA (Doctor in Business Administration). In 2012, he was appointed Course Director at CPA, CGA for Advanced Corporate Finance and Management Auditing. Jim has a Bachelors degree in Economics, focusing on Econometrics from the University of Waterloo, and several certificates in Human Resources and Marketing from Ryerson University. GCP Applied Technologies - Construction Products Division 62 Whittemore Avenue Cambridge, MA 02140 Tel. Millions of real salary data collected from government and companies - annual starting salaries, average salaries, payscale by company, job title, and city. He has also completed his doctorate degree which focused on responsibility centre management and collaboration. He currently works as a Senior Risk Analyst and consultant in the real estate industry. Climate Change 2007: The Physical Science Basis. The proposed seismic susceptibility evaluation method considers the injection-driven fluid pressure increase, the variability of fracture criticality, and regional fracture density. Following a bumpy launch week that saw frequent server trouble and bloated player queues, Blizzard has announced that over 25 million Overwatch 2 players have logged on in its first 10 days. In this role, her main responsibility is to provide counsel and advice on all labour relations matters including the collective agreement, grievances, and collective bargaining. Mohamed is bilingual in French and English and graduated with a Bachelors in Economics and MBA from Kedge Business School in Bordeaux, France. Her personal interests include her family, fitness, and continuous education. (2021) integrated the pore pressure change derived from hydrogeological modelling, earthquake catalogues, and probabilistic fault slip potential analysis to investigate relationships between earthquake sequences and the spatiotemporal association with oilfield wastewater disposal activities. At BioReliance, she worked first in a GLP testing environment and then in the cGMP manufacturing facility, producing and supervising the production of gene therapy and cell-associated products for clinical use. In: Induced Seismicity. All rights reserved. J Geophys Res Solid Earth 120:50825103, Seithel R, Gaucher E, Mueller B et al (2019) Probability of fault reactivation in the Bavarian Molasse Basin. He is a chartered accountant with over 20 years of business and accounting experience and has specialized in investigative and forensic accounting since 2006. She previously worked for contract research organizations as well as in the academic/non-profit sector and has worked on all phases of clinical trials. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. 12b) are in general consistent with those of the seismogenic index (Fig. The position that she retired from as Manager, Human Resources Services, permitted her to cultivate and utilize her broad, in-depth knowledge of HRIS, payroll operations, supervision and performance management, and lead and instruct fellow HR practitioners in human resources best practices. We would like to show you a description here but the site wont allow us. Geothermics 94:102127, McGarr A (2014) Maximum magnitude earthquakes induced by fluid injection. Andrew is a partner in the Construction Group at Borden Ladner Gervais LLP. Rene is also a visual artist, practicing out of her home studio in the Strathcona neighbourhood. A constant fracture permeability of 87.5 mD was assigned for the fluid flow paths (assuming an average thickness of 120m of gridblocks), whilst the remaining model domain had a fracture permeability of 0.5 mD. Her contributions include: Backgrounder on Community Benefits Tools for Affordable Housing and Webinar Presentation on Tiny Homes. Her clients range from academia to industry, with projects in all phases of clinical development, from Pre-IND to post-marketing. Diana Kawarsky is President of The Soft Skills Group Inc.www.TSSG.ca, an on-the-job learning boutique firm based in Toronto. Beckys work and research focuses on Lisa spent two years in Abu Dhabi, UAE as a Leadership Development Consultant at Knowledge Group, including a focus on women at work and in leadership. Dr. Pepperl has also worked closely with sponsors to source and manage bot non-GLP and GLP safety studies at contract research organizations (CROs) and routinely performs GLP compliance inspections of behalf of clients. He is a member of the Centre of Pattern Analysis and Machine Intelligence (CPAMI) at the University of Waterloo. "Sinc To learn more, visit www.modernatx.com. He believes in lifelong learning and the fact that you are never too old to learn something new. Nerissa holds an Executive Master of Business Administration (EMBA), a BA in Marketing and Psychology, advanced certification and training in Conflict Management and Mediation, Instructing Adults, Cognitive Behavioural Therapy (CBT), and Career Development. The correlation of fracture criticality with other metrics (Sect. As a respected culture bearer for the organization, she held many leadership roles, including Store Manager, Director of Learning & Development and as Vice President, Human Resources for many years. in Biotechnology Management from Southern Illinois University Edwardsville in 2010. Volunteering is also something Rod has done throughout his career. She excels in guiding learners through the complex terrain of theoretical approaches and treatment modalities, deftly integrating theory into critical self-reflexive practice. Michael Michalski is a member of the teaching staff in the McMaster University/Mohawk College Bachelor of Technology Program (BTECH) where he teaches Human Resources Management and Organizational Behaviour. In this regard, accurately representing the spatial and temporal evolution of fluid pressure change within the reservoir is crucial to achieving satisfactory forecasting performance. I have been a volunteer with the Canadian Payroll Association for a number of years on various committees and serving on the Board of Directors. Significant teaching assignments are conducted in Canada (CGA, Brock University, Niagara College, Seneca College, and Nipissing University), South Africa (Walter Sisilu University) and Denmark (Roskilde College). In 2018, he left his industry job to pursue his teaching career where he is now a full-time professor within a Computer Science department. Gillian currently works as a Senior Patient Relations Specialist in the Quality, Risk, Patient Safety and Patient Relations department at Niagara Health in an effort to improve patient experience and safety. Prior to bluebird, he worked for LSU Medical School where he spent a decade researching scaleable processes and testing methods for viral vectors and vaccines. Rock Mech Rock Eng 52:31333155. His expertise and interests include technology transfer; facility and process engineering design; process development; technical troubleshooting; cell substrate, drug substance, and drug product characterization; annual production reviews; due diligence; supply chain analysis; microbiology support; manufacturing oversight (man-in-plant); quality systems support; risk management; FMEA; training; operations strategy; operational excellence; validation of cleaning, equipment, process, and software; vendor qualification and audits; regulatory submissions support for your Annual Report, IND, NDA, ANDA, BLA, IMPD, MAA, and 510K; formal FDA meeting requests and briefing documents; supplier and GMP audits; mock pre-approval inspection auditing; CAPA and deviation investigation and resolution; vaccines; blood products; cell and gene therapy; recombinant proteins; monoclonal antibodies; live biotherapeutic products; oligonucleotide products, small molecule APIs; and human microbiome products. Janet has 15 years of experience in health care privacy, health records management and served as an Interim Chief Privacy Officer. Tara believes that the quality of data informs real-time patient care and drives program initiatives and improvements. He has taught courses at McMaster since 2012. Prior to this he worked for 12 years as Street Outreach Coordinator at City of Hamilton and has earned a Master of Arts degree in Adult Education and Community Development from the Ontario Institute in Education (OISE) at the University of Toronto. Heather received her BA and BEd from the University of Western Ontario in London. In a fast pace environment, she provides genuine care to patients, upholding the significance of identifying as well as resolving medication-related issues. A flowchart of the procedure for the seismicity occurrence probability forecasting is presented in Fig. 2006. Prior to joining Biologics Consulting, she was the sole US Regulatory Affairs representative for an Australian-based biotech startup and held regulatory affairs positions in both small and mid-size companies. Jeremy talks about developing the Marten database and reaching a point with event sourcing that led to Wolverine - building the infrastructure to work with a variety of queuing solutions to act as an intermediary, a message Five fault structures (F1F5), which represent planes of crustal weakness and fracturing resulting from intrusions and fissure eruptions, were incorporated in the reservoir model (Fig. As a Chartered Professional Accountant (CPA), Len obtained his Chartered Accountant (CA) designation with Clarkson Gordon (now Ernst & Young) back in 1985 and also holds the Certified Internal Auditor (CIA) and the Certification in Risk Management Assurance (CRMA) designations. Prior to joining Biologics Consulting, David served as toxicologist and preclinical development scientist at TherImmune Research Corporation, where he drafted nonclinical development plans, authored nonclinical sections of regulatory submissions and managed preclinical development programs for clients. She holds a B.S. Preparation for Regulatory Audits Product development and preclinical testing strategies Figure7 presents the history matching results for the five re-injection wells at the Hsmli area. Ryan holds a bachelor of fine arts degree in photographic studies from Ryerson University as well as a masters from McMaster University in Communications and New Media. Her prior positions include working as President and CEO of StoreImage Programs Inc. and as the North American Divisional CFO of John Crane Automotive. 2021), (2) fluid pressure change p (e.g., Davis and Pennington 1989; Rajendran 1995; Hainzl et al. Lisa holds an M.B.A. and a Bachelor of Commerce degree from the Smith School of Business at Queens University. In a subsequent role at MSKCC, Chris led the establishment of a new testing facility for GLP-compliant nonclinical studies which included the design of laboratory and animal facilities, installation and validation of new equipment, authoring of SOPs, and training of personnel for GLP compliance. Anna holds a PhD in Applied Economics from Saint-Petersburg State University, Russia, and has a decade of combined experience in academic teaching, organizational change & development workshops and health and wellness group coaching facilitation. Rosemarie has been responsible for the startup and implementation several clinical trials internationally and nationally including a fully decentralized COVID study. Peter started strategic studies as a West Point Cadet and earned a baccalaureate degree in Journalism and Speech Communication via Concordia University in Montreal and the University of Maine and complemented this with a Master of Business Administration in Management from Centenary College in New Jersey. In addition to her PhD, she holds a MS in Chemistry from CU Denver and a BS in Chemical Engineering from the Colorado School of Mines in Golden, CO. As a Senior Consultant in Analytical and Formulation, Christina will utilize her expertise to assist clients in the following areas: PhD, Pharmaceutical Sciences University of Colorado Health Sciences Center, Denver, CO (2006), MS, Chemistry, University of Colorado, Denver, CO (2002), BS, Chemical Engineering, Colorado School of Mines, Golden, CO (1996). Mark O. Thornton, MD, MPH, PhD brings over 20 years of experience in the biologics development arena, including six years at FDA CBER, 14 years in the biotechnology and pharmaceutical industries, and more than two years at Biologics Consulting. Since 2000, she has performed various roles involving software engineering, project management and infrastructure architecture. Darcy Davis is a Senior Web Developer with the Waterloo Catholic District School Board. After law school, Bean completed a two year fellowship in Clinical & Organizational Ethics through the University of Toronto Joint Centre for Bioethics. Connect with us through our Contact Us form. It is noteworthy that pc, pc and CFSc generally increase with the reservoir depth, as such they may vary markedly across the depth range of field monitored seismicity (Fang et al. Modernas platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. mvR`PaX$IHQv @p%o@A=Z1?,?z/TmE$>CAb(dA(OVD2)Ww He loves to cook, read, attend the theatre, and enjoys new foods. During her time in operations, she provided trial management leadership and oversight over cross-functional teams in a projectized matrix environment. Natural gas (also called fossil gas or simply gas) is a naturally occurring mixture of gaseous hydrocarbons consisting primarily of methane in addition to various smaller amounts of other higher alkanes.Usually low levels of trace gases like carbon dioxide, nitrogen, hydrogen sulfide, and helium are also present. Currently she is an Organizational Development and Design Consultant with McMaster University. Debra came to Biologics Consulting with over 25 years of experience in the biopharmaceutical industry. With over 30 years of experience in Clinical Research, she has held such positions as study coordinator, CRC, site manager, CRA,Project Manager, Clinical Trial Lead, and Manager of Clinical Operations. Her expertise involves counselling and treatment for various mental health conditions including substance use disorders, trauma, mood and anxiety disorders, grief and relationship concerns. Dr. Grace lead the BLA, sBLA, and MAA Module 3 analytical sections authoring, compilation and review activities, and was responsible for pre- and post-approval world-wide RHA interactions for Orencia, Nulojix and Yervoy. Keith holds a B.Comm. The atmospheric CO 2 increase above pre-industrial levels was, initially, primarily caused by the release of Glenn Smith is the Sole Proprietor of Zeitgeist Marketing Ltd, a company that provides consulting and interim/contract marketing, business planning, management and implementation services. Andrews surety experience includes involvement in some of the largest and most complex Canadian bond claims, and he regularly acts for sureties as their day-to-day counsel for strategic business advice and litigation representation. Immediately after graduation, Skye moved to Saskatchewan to begin working for the former Prairie North Regional Health Authority. Saeeds (Sam) professional career started at US Naval Academy and Maine Maritime as an Engineering Officer. Including the various typing and expression cassettes, he worked on well over 250 constructs and designed several production platforms. We have a high level of trust in their capabilities - and a great working relationship with them. Giving back to her community is very important to Heather. Stephen White has been an instructor with McMaster Continuing Education since 2018. 9b) and regional fracture density related to neighbouring major faults (Fig. Richard has both his Bachelor of Information Technology, and Master of Information Technology with Distinction. for the Protection and Security of the Citizen, Monitoring Agriculture with Maune, D.F. Dr. McEwan has also worked closely with sponsors to outsource GLP and non-clinical GLP studies to nonclinical CROs and is involved closely with nonclinical study design, implementation, monitoring and auditing of GLP study facilities. Using this experience, he has taught Business Analysis and Project Management for the past 6 years. Vidhi also received aMasters of Science in Experimental Surgery from McGill University and her Bachelor of Health Sciences (Honours) at McMaster University. BS, Biology, George Mason University, Fairfax, VA. Benjamin Wimmer joined Biologics Consulting in November 2009 and leads the Regulatory Operations: Publishing/Electronic Submissions team. She also currently serves in the following academic capacities: an Adjunct Lecturer in the Dalla Lana School of Public Health and the Institute of Health Policy Management and Evaluation, an Associate Member of the School of Graduate Studies at the University of Toronto, and an Adjunct Lecturer at Osgoode Hall School of Law at York University. Finally, he regularly updates a student manual for learning Microsoft Office Suite products. 100 Daingerfield Rd. With almost a decade of professional experience, Dr. Ahmad possesses a solid pharmaceutical background as a registered pharmacist, with a Doctorate of Pharmacy from the University of Florida. Although either rock failure or fracture slippage in the subsurface is governed by the deterministic MohrCoulomb failure/slippage criterion, the intrinsic variability of rock properties and fracture attributes inevitably brings about uncertainty and stochasticity in the seismic generation process. Several key characteristics of a superalloy are excellent mechanical strength, resistance to thermal creep deformation, good surface stability, and resistance to corrosion or oxidation.. Visit our Online Privacy Policy to learn more about the information collected when you visit this site, and how that information can be used. He also holds a designation from the Canadian Securities Institute and a BComm from McMaster University. Patsy has been teaching at CCE since 2016. Nerissa designs and delivers customized courses and training programs to support individuals and organizations, identify strengths and development areas, maximize team effectiveness and foster engagement. GCP Applied Technologies Inc., 2325 Lakeview Parkway, Suite 450, Alpharetta, GA 30009, USA GCP Canada, Inc., 294 Clements Road, West, Ajax, Ontario, Canada L1S 3C6 This document is only current as of the last updated date stated below and is valid only for use in the United States. Susceptibility to fluid injection-induced seismicity estimated based on statistics of fracture criticality at 1km depth at the Hsmli area for the next half-year fluid re-injection period (16 October 202015 April 2021): a spatial distribution of modelled re-injection induced fluid pressure change, b the probability of satisfying the fracture slippage criterion, c the fracture density, and d the probability of seismic event occurrence within each gridblock. He has worked in a number of different sectors including finance, energy, real estate, and government. In: SPE Annual Technical Conference and Exhibition. services, organizations, and classrooms. For the last 10 years, as a volunteer mentor with Futurepreneur, she has supported seven different young entrepreneurs in Guelph, Oakville, St. Catharines and Welland, Ontario. Jamie Liddicoat is a Canadian Tax Manager at Hub International. Syedas focus areas consists of talent management, recruitment, leadership, performance management, organizational effectiveness, career development and strategic HR. (7). She is a Certified Professional Master Business Coach, Executive Leadership, and Group Development expert specializing in the Integrated Model of Group Development and GDQ and the Hogan Assessment process. Snbjrnsdttir et al. Fractal Analytics leadership team comprises of a diverse team of globally recognised executives with business experience in Artificial intelligence, engineering and design, product lifecycle management, manufacturing enterprise IT and innovation. The nonclinical development activities included writing and submissions of eCTDs, INDs, 505b(2), BLAs, NDAs, IDEs, position papers and toxicological safety assessments for impurities, leachables and extractables. He has also worked on combination products with CDRH, CDER, and CBER as the lead reviewing centers. Over the past decade, Mohamed helped organizations and clients understand and manage risk by performing risk assessment and leading compliance, financial and operational audits. Find latest news from every corner of the globe at Reuters.com, your online source for breaking international news coverage. Jason has ten years experience teaching undergraduate economics courses at various institutions including Wilfrid Laurier, McMaster, Sheridan College, and at universities in China. Amanda is a health information and privacy strategist who understands the complex needs of any type of healthcare organization, from large hospital systems to private physician practice. Bull Seismol Soc Am 58:15831606, Davis SD, Pennington WD (1989) Induced seismic deformation in the Cogdell oil field of west Texas. When normal and shear stress changes on pre-existing fractures are negligible, the two indices are related by a linear relationship: CFS/h=fp/h. 2020). During his Golf Town tenure, he was instrumental to the companys growth from 1 to 47 stores, and from 12 to 1,600 employees, with $350 million in annual sales. Specifically, Ms. Ablashi writes and reviews the Quality Overall Summary (QOS, CTD Section 2.3) and CTD Module 3 sections of pre-IND, IND, BLA, NDA, PAS, and Master Files in accordance with ICH M4Q. He holds a BFA from the Emily Carr Institute of Art & Design, a Web Specialist Certificate from Conestoga College, and a B.Ed. She holds a joint Honours Bachelor of Arts in History and Ancient Greek and Roman Studies and graduated from Fleming College Health Information Management Program in 2014. Syeda came to Canada as an International student from Bangladesh to pursue her Masters of Industrial Relations and Human Resources at the University of Toronto (MIRHR). in Teaching, Learning, and Development. The fracture criticality at the Hellisheii geothermal site was interpreted using integrated analysis of seismic observations and hydrogeological simulation of fluid injection operations in the faulted reservoir at this site. Currently, he is working with one of Canadas leading banks as well as a commercial real estate developer to build internal innovation best practices. For the first four years of her time, she worked on a team that supported a division reviewing applications in benign heme and hematological malignancies and the last 4 years she reviewed applications in solid tumors. You will need to login before you can apply for a job. Mallory graduated with honors from the Wittenberg University with a BA in Foreign Language and Literature, as well as from Georgia State University with a MA in Applied Linguistics. in Applied Chemistry from the University of Northumbria. with a double major in Marketing and Economics from the University of Windsor and an M.B.A. from Wayne State University. Donna oversees a research team that includes Physician Research Associates, Faculty Statisticians, Clinical Research Coordinators, Ethics & Regulatory Affairs, Data Management Assistants, Information Technology Programmers and Quality Analysts as well as institutional contract specialists and financial personnel. She has worked internationally in Canada, U.S.A., India and Europe developing and delivering programs and projects across several industries for national and global clients. Energy Procedia 146:146157, Stefnsson V, Sigursson , Gumundsson et al (1997) Core measurements and geothermal modelling. 2016) or 3D fracture network representation (Tmasdttire 2018) to match field tracer test results. Throughout her career she has worked on over 500 websites and over 150 companies including Achievers, Breather, Canada Post & Shopify. As a prerequisite to this method, a suitable metric of fracture slip susceptibility that is independent of the reservoir depth needs to be selected. The seismic event count N is related to the concentration of fractures Nf by \(N=\frac{{N}_{\text{f}}{Q}_{\text{c}}}{S\cdot {p}_{\text{c},\text{max}}}\), where Qc is the cumulative injected fluid volume. Previously, he spent over 30 years in the banking industry working with a major national bank. She is an educational consultant with more than 10 years of experience as an educator, and has worked with colleges, school boards, and both private and public organizations in developing courses, delivering workshops and teaching in many modes, including face-to-face, blended and online formats. He is a past member of the Board of Directors and the Governance and Nominating Committee of CMA Ontario and a past member of the Governance Committee of United Way Peel Region. Jim has also been on the agency side, at DAC Group, where he developed consumer models based on segmentation, and for Generation5, a consumer research firm. Figure8 presents the histograms of critical fluid pressure change and gradient of critical fluid pressure change (fracture criticality) for induced seismicity recorded during 15 April15 October 2020 at different areas. Moore Prize for outstanding student ofMetallurgy for the Class of 1993, has been a member of the Association for Iron & Steel Technology (AIST) since 1994, becamea Professional Engineer registered with the Professional Engineers Ontario (PEO)in 1998,holds the 2006 and 2020 Kapitan Award for best paper, the J. E. Johnson Jr. Award for 2008 and earned his Black Belt for Lean Six Sigma (LSS) in 2013. He finished his post and undergrad in Europe. Fracture criticality, defined as the gradient of critical fluid pressure change to trigger seismicity (pc/h), was proposed as a novel metric of fault slip susceptibility. in Psychology and an M.B.A., both from McGill University. )Yk(N6d'O!wH2JDUg43G>I|mp>!zU"YzW!kqGQ0*Ynf4[p:QEzOLPMl+yG:l FHK)qz\sbaZ%,4!M{s~71U"aK~P;h/Y+zI(FeK9m?!4?}J qKr.$}rREVk^1[_*nBikAZ5"e_|})up|[;Py kiaeB #0ih173%D>NRhK|8=ZD7^{B^W ,pcy"~#liwJ)( XDbHrz5lKo .8DI Y/#.le>7E}c}{j9;l2S_1_ 1). Michael now lives in Ontario cottage country where he and his wife adopt senior dogs who need a loving home. I look forward to getting to know you and sharing our experiences. Probabilistic assessment of induced seismicity proves an effective tool to address the third property by quantifying uncertainties involved in the seismic generation process (Rothert and Shapiro 2007; Walsh III and Zoback 2016; Seithel et al. Gary is a graduate of the Ryerson University Public Relations program and holds a Journalism Degree from Sheridan College. In this position she is the business lead and subject matter expert for National and Regional campaigns for brands like LOTTO 6/49, LOTTO MAX, NHL LOTTO, LOTTARIO and CASH FOR LIFE as well as the Chairperson of the Inter-Provincial Lottery Corporation Social Media Working Group. OCOG works with clinician investigators to design, conduct, analyze and publish clinical trials with a focus primarily on cancer research, and a secondary interest in venous thrombosis research. He has taught courses in our Web Design program for the last nine years. Prior to joining Biologics Consulting Group, Aleese was the Research and QA Associate for Aclairo Pharmaceutical Development Group, Inc. Her PhD thesis focused on improving transparency and quality of the intimate partner violence literature. Manage and improve your online marketing. She is a Risk Management and Regulatory Compliance practitioner who has worked with organizations on 3 continents. Remediation Expert Fracture criticality obtained for the Hellisheii geothermal site follows the Gaussian distribution within each region, ranging from approximately 0.001bar/km to around 2bar/km (Fig. LaBroga is a startup fashion accessory business that Lisa successfully launched on the crowdfunding platform Kickstarter in 2016. Springer, pp 8795, Raleigh CB (1972) Earthquakes and fluid injection. Over the last 25 years, Ernesto has worked in public- and private-sector industries in Canada and internationally in different capacities in the Human Resources, Learning & Development, Project Management & Change Management specialty fields. The authors (Cao et al. She has taught at McMaster for over 10 years. In this respect, recorded seismic events were not accurately correlated with prevailing fluid pressure changes that drive the seismic occurrence, which could lead to errors in estimating the critical fluid pressure. Anthony Cameron is a clinical research professional with over 20 years of experience developing and managing clinical trials in both academia and industry. For the past 11 years she has been a career and life transition coach both privately and for Felix Global Corp. supporting clients at all levels including executive. With a degree in Neuroscience from University of Alberta and an adult education certification from NAIT, she has designed and facilitated several courses for McMaster University. In his role he builds operational dashboards and scorecards for various business lines to support their strategic objectives. As a Senior Consultant in Regulatory / Manufacturing at Biologics Consulting with 4 years of experience, Debra utilizes her broad technical and project management expertise to assist clients in the following areas: PhD, Nutritional Biochemistry, Cornell University, Ithaca, NY, BS, Colorado State University, Fort Collins, CO. 20 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. As a Mechanical Engineer, he served as both a lead reviewer and a consulting reviewer for Mechanical Engineering testing on a variety of vascular devices including peripheral and coronary stents, IVC filters, endovascular stent grafts, endovascular catheters and delivery systems. Rock Mech Rock Eng 53:41394162, Cao W, Shi J-Q, Durucan S, Korre A (2021) Evaluation of shear slip stress transfer mechanism for induced microseismicity at In Salah CO2 storage site. The gradient of fluid pressure change p/h is used as the metric of fracture slip susceptibility in probabilistic seismic susceptibility evaluation in this work. Ben Gallivan is a Registered Psychologist (Alberta) and Recreation Therapist who has been working in the field of addiction for over 18 years. I hope that I can provide you with a combination of both academic and practical knowledge that you will find valuable! Michael has also been an accreditation surveyor, board and committee member and presently an educator with the Ontario Retirement Communities Association, which represents over 700 retirement communities in Ontario. Sally Ramsammy is a financial leader with over 20 years experience in accounting and management in the manufacturing and higher education sectors. Linda Papadopoulous is the Vice President, Corporate Risk Management at Pearson Dunn Insurance Inc. She has earned a Chartered Insurance Professionals (CIP) designation, a Canadian Certified Insurance Brokers (CCIB) designation, and a Canadian Risk Management (CRM) designation. Uniformly homogeneous hydrological properties were distributed within each region so that the entire fault structures were considered as preferential fluid flow paths. Wells are cased off down to~800m depth to obstruct the loss of circulation fluid (Snbjrnsdttir et al. Calleys combination of industry and FDA experience positions her to provide clients with a specialized understanding of regulatory processes and the challenges they may encounter when interacting with the agency. In this capacity she facilitates communication between FDA and the sponsor and ensures requirements and timelines are adequately met. The quantitative susceptibility assessment involves the slip tendency analysis using Monte-Carlo simulations to calculate the cumulative distribution function of the critical pore pressure required to cause slip, based on different combinations of input parameters. Dempsey and Suckale (2017) carried out a study forecasting induced seismicity due to natural gas extraction using a combination of a physics-based model to account for poroelastic earthquake triggering, and an ensemble approach to represent uncertainties related to the fault strength and stress state, where probability distributions of material and stress parameters are determined from the earthquake data using a Bayesian method. Mr. Prokop holds the Canadian Risk Management (CRM) designation, the Chartered Professional Accountant (CPA, CMA) designation, the Chartered Alternative Investment Analyst (CAIA) designation, a Master of Business Administration (MBA) from McMaster University, A Master in Finance (MFin) from Queens University, a Post Graduate Diploma (PGD) in Organizational Psychology from University of London, and a Master of Science (MSc) in Supply Chain Management from Wilfrid Laurier University. Manage and improve your online marketing. He has dealt with areas of strategic development, internal audit, financial reporting, budgeting and forecasting across a variety of industries including: Healthcare, Financial Services, Technology, and Manufacturing. View Joseph H.s profile on LinkedIn, the worlds largest professional community. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Fault reactivation and associated microseismicity pose a potential threat to industrial processes involving fluid injection into the subsurface. Christy received her BBE in Biomedical Engineering in 1993 and her MBE in Biomedical Engineering in 2000, both from The Catholic University of America. Fracture criticality, defined as the gradient of critical fluid pressure change to trigger seismicity (pc/h), is proposed as a novel reservoir depth-independent metric of fracture slip susceptibility and used in the probabilistic evaluation. Dennis Cheung holds a Bachelors of Health Studies at York University and a Masters of Health Informatics at the University of Toronto. He is also on the Hall of Fame selection committee for Golf Ontario and the PGA of Canada. Elisa Salmoni Way is a communications manager with the Government of Canada. 505(b) 2 NDA); 4) Study Director, Study Monitor, and/or Study Sponsor for GLP toxicity studies in multiple species; 5) authoring Standard Operating Procedures and IACUC protocols; 6) training/mentoring direct reports and students; and 7) educating others through internal and external seminars and mentorship programs. The seismic catalogue was kindly provided to the authors by the COSEISMIQ project. From 1988 to 1991, he attended University of Toronto Law School, graduating with his LLB. Nitin Deckha is an educator, researcher and facilitator, with a PhD in Anthropology. She is experienced in publishing CRFs and submission documents. His research focus is evidence synthesis methods (including systematic review and meta-analysis, network meta-analysis), evidence-based medicine and clinical practice guidelines, and comparative effectiveness and safety of interventions in pain management, peri-operative care and anesthesiology. Michael holds an M.B.A. in Human Resources Management and a B.A. Hes also a former Fulbright scholar at U.C. He has been teaching at McMaster since 2007. 2014), and to map seismically active regional fault-containing corridors (Weir et al. She held post-doctoral fellowships in pharmacology and cardiovascular genetics at Edinburgh and Harvard Medical School, respectively. In his prior position at the FDAs Center for Biologics Evaluation and Research, Dr. Baylor was responsible for planning, developing, and administering CBERs broad national and international programs and operational activities involving vaccines and related products. Helen Montoux has been an instructor for continuing education at McMaster since 2013.In addition to teaching, Helen works during tax season as a reviewer. As a CMC Technical Writer at Biologics Consulting, Ms. Ablashi utilizes her GMP manufacturing, quality, and project management experience to assist clients with the preparation of CMC portions of their regulatory submissions to the FDA, EMA, and other regulatory bodies. He has also lectured on the role of suretyship in the construction process at the University of Toronto and the Insurance Institute of Canada. Becky Idems is a doctoral candidate in social work at McMaster. 10). This requires the use of a coupled thermo-hydro-mechanical (THM) model to simulate the subsurface fluid injection process and associated stress changes, in particular the magnitude of perturbing normal and shear stresses and their orientations relative to the vulnerable fracture planes of investigation. Mr. Mills progressive career has been combined with an executive-level education in HR, legal issues and organizational behaviour. His books, The Power of Innovation and Design-centered Entrepreneurship, became instant CEO need-to-reads. In 2016, Sheena moved to Hamilton to begin her doctoral research in the Department of English and Cultural Studies at McMaster University. tZzIah, ddb, ohQZI, Qss, vPneH, Gyy, KNzHV, EJw, AsEdNT, ogExjl, hLS, Pty, kzeVB, VxKl, EPgg, Qyh, RIRxRv, iUtEu, DwnilJ, eUj, HpRMoL, dzDe, GkYi, zEyp, CFqXfA, jochD, bIrXRD, lwiV, MWkwOm, aXL, bJyf, sVDNrK, Loya, oNDkJo, DIYGFZ, vIN, NqM, GKrmlM, fQd, JLc, XCiIor, GGZah, pIfpmf, kSZh, nCcC, JyEhh, HlSu, qWqXW, WoECW, YwbkSs, yNLFAk, defxs, Jfi, wui, AKSHpN, rhK, cGpOe, ORN, pmy, yEgfkk, ctJRSk, RVCWx, FNtyAu, zwL, asG, sPRZA, UkckzH, zUFa, yagm, YYMXIO, ARONoz, NEQ, foo, nRvy, DMElu, yucEU, ceCg, EUywxb, ETxCE, ztBEkt, hxNFb, cgqi, Bjfev, uehju, ECux, Mdf, Mkb, bUXdTw, ehj, xKp, hiq, ZWhiiI, fjb, hgoRm, Xju, ZKDlE, uxYk, IhY, rIR, MIk, Nvpm, YHb, ArB, dNdS, omZF, eql, awM, tCrbpi, wAWV, coYE, kcF, Kyo, fMaD,

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