Drug Safety Reporting Requirements: Best Practices for Monitoring, Reporting and Avoiding Regulatory Missteps – Webinar Recording/Transcript
Whether premarket or postmarket, pharmacovigilance is serious business. Fail to comply with drug safety monitoring or adverse event reporting, and the consequences can be dire — for patients and for you.
Premarket drug safety monitoring and reporting is vital to the FDA’s risk-benefit evaluation and in determining what information should be included in the drug’s label.
Postmarket requirements facilitate the detection and evaluation of adverse events that may not have been discovered during clinical studies, helping to ensure that drug product labeling — including warnings — incorporate changes.
The FDA’s evaluation of safety risks and adverse events can lead to a drug’s removal from the market. Failure to comply with pharmacovigilance requirements can mean regulatory action; it can also mean civil or criminal enforcement by the Department of Justice.
Beth Packman Weinman — counsel in Ropes & Gray’s life sciences regulatory and compliance practice group and former associate chief counsel for enforcement within FDA’s Office of Chief Counsel — explains what you must know and do to ensure compliance.
Using real-world examples, she provides you with a sophisticated understanding of pharmacovigilance, best practices for monitoring sources of complaints, how to comply with reporting requirements and the consequences of failing to comply.
- Why pharmacovigilance matters — includes recent real-world safety alerts (unexpected cardiac adverse events among young males associated with certain vaccines; behavior and mood changes associated with a popular asthma and allergy drug) and drug safety reporting that led to the removal of warnings
- How to comply with premarket and postmarket adverse event reporting requirements — includes what information must be reported, to whom, how, on what forms and within what required time frames
- How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public
- When and why there is a phase 4 (postapproval) study requirement for drugs subject to accelerated approval
- What a company’s obligations are for monitoring sources of safety information and tracking complaints, including with respect to social media
- When reported adverse events might lead to an FDA Safety Communication — or a request for a recall
- What the regulatory and judicial enforcement consequences are of failing to comply with drug safety reporting requirements — includes recent real-world warning and untitled letters citing reporting failures and DOJ settlements focusing on such allegations
Pharmacovigilance is too important to get wrong. This webinar will ensure you get it right.
Meet Your Presenter
Beth Packman Weinman, counsel, is a member of Ropes & Gray’s life sciences regulatory and compliance practice group. She focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and foods, including dietary supplements. Ms. Weinman represents clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, and other enforcement actions before state and federal regulators, and also represents clients in administrative litigation matters. She also provides counseling on issues related to marketing practices, current good manufacturing practices, good clinical practices, compounding, medical product development and approval, and product recalls and withdrawals. Prior to joining Ropes & Gray, Ms. Weinman spent nearly eight years as associate chief counsel for enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with the FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecuted alleged violations of the FDCA and related crimes under Title 18 (including mail fraud, wire fraud, healthcare fraud and conspiracies to defraud). She also worked on numerous parallel and independent FCA investigations involving FDA-regulated drugs and devices, including biologics.
Who Will Benefit
- Regulatory/compliance personnel
- Drug sales representatives
- Clinical marketing personnel
- Personnel interfacing with patients taking prescribed medications
- Advertising/marketing personnel working at or for drug companies, especially those working in social media
- CROs and those in clinical research with reporting responsibilities
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Dec. 9, 2021