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 — will explain what you must know and do to ensure compliance.
Using real-world examples, she will provide 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.
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