Hi Regex Members,
The first quarterly Regulatory Focus (RF) Articles Series of 2019 is here! In this RF series, you will find a collection of insightful articles covering the latest risk management principles. It is a pleasure to bring together some of the world's leading regulatory professionals-all with diverse backgrounds-to offer a comprehensive update on the emerging and evolving field of therapeutic risk management.
Individual articles examine:
Emerging Trends in Risk Management for Pediatric Patients
Postmarket Surveillance in a Digital Health Solution World: Challenges and Opportunities for an Evolving Industry
The Enforcement of Risk Evaluation and Mitigation Strategy (REMS)
Medicinal Products Benefit-Risk Management: the Role of Patient Input
Implications for Pharmaceutical Risk Management in the 21st Century Cures Era
Medical Device Risk Management
How FDA is Using REMS to Help Manage the Opioid Crisis
Risk Management: What Regulatory Professionals Need to Know
Download the latest RF Articles Series here.
Mark <g class="gr_ gr_50 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="50" data-gr-id="50">you</g> Calendars: To support the launch of the Article Series, we will be hosting an "Ask Me Anything" session on Wednesday, 13 March, from 1:30 PM-2:30 PM EDT here on RegEx. Three risk management experts, Darin S. Oppenheimer, Merideth Y. Smith, and Ann K. Walsh will be available to discuss the articles and answer your questions in real time.
About the experts:
Darin Oppenheimer, DrSc, RAC, FRAPS, is an executive director of the <g class="gr_ gr_56 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="56" data-gr-id="56">drug device</g> center of excellence focusing on medical devices and combination products at Merck based in Upper Gwynedd, PA. Oppenheimer is involved in many facets of the product development lifecycle, including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees over the past 15 years. His prior background as a research and development scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. He holds two master's from Johns Hopkins University in biotechnology and regulatory science as well as a <g class="gr_ gr_55 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="55" data-gr-id="55">graduate</g> Certificate in biotechnology enterprise. Recently Oppenheimer completed his Doctorate degree in regulatory science from the University of Southern California. He is also a 2017 Regulatory Affairs Professional Society Fellow.
Meredith Y. Smith, <g class="gr_ gr_53 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation multiReplace" id="53" data-gr-id="53">PhD</g>, MPA, is <g class="gr_ gr_52 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="52" data-gr-id="52">global</g> risk management officer, global patient safety and labeling at Amgen, <g class="gr_ gr_54 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation multiReplace" id="54" data-gr-id="54">Inc..</g>
Anne K. Walsh is a director at Hyman, Phelps & McNamara, PC. She counsels clients on compliance and enforcement issues, including FDA inspections, seizure and injunction actions, warning letters and recalls. She focuses on defending companies against allegations of fraud related to marketing and promotion, cGMP and QSR, healthcare and clinical studies, with particular emphasis on cases involving joint criminal and civil investigations under the FDCA and the False Claims Act (FCA). She also has successfully sued the government for violating the Administrative Procedure Act (APA). She applies her enforcement expertise to aid companies in compliance efforts, via internal investigations or risk assessment audits.
If you cannot make the session, please feel free to submit any questions ahead of time by replying to this discussion or sending me a private message.
Looking forward to hearing your thoughts on this article series.
Best,
Emily
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Emily Stamm
Community Manager
Regulatory Affairs Professionals Society®
regex@raps.org------------------------------