Post-Pandemic Pharmaceutical Regulations – Webinar Recording/Transcript
Post-Pandemic Pharmaceutical Regulations: COVID-19’s Impact on Drug Approvals and Postmarket Surveillance
What will the post-pandemic pharmaceutical world look like?
The pandemic has disrupted everything: the global pharmaceutical supply chain, the ability of global regulators to move pending applications forward for new drugs and provide in-person oversight of postmarket signals, and the supply of necessary active ingredients (most of which are manufactured in Asia).
Overall, COVID-19 has made drug shortages a far bigger concern.
The result is that regulators are putting forth new guidance and legislation to mitigate disruptions and are making an effort to alleviate potential supply chain issues. Both FDA and industry players are making long-term changes to how they think about and execute business objectives.
You can’t afford to be left behind.
Ricki Chase will help you manage the current state by explaining where things are and what you must know about the post-pandemic regulatory environment. An executive director in the compliance practice at Lachman Consultant Services, Inc. and a former FDA regulator and investigator, Ms. Chase will share how to prepare for what’s to come by discussing the impacts to the drug supply chain and what a post-COVID world might look like, including the regulation changes coming from the FDA and other regulators.
- The impact on FDA approvals for COVID-19 drugs and other pharmaceuticals, and how FDA will recover and move these forward post-COVID
- The effect on postmarket surveillance and options for FDA to move this forward, including postmarket communication in a pandemic and implications for future requirements in terms of compliance with postmarket surveillance guidelines
- Modifications of clinical expectations and implications for post-COVID operations, including what it might mean for recruitment and operation of clinical trials
- Long-lasting consequences of delayed FDA work plan execution
- Special considerations, such as compounding to address shortage issues
- Emergency Use Authorizations (EUAs) and their significance to the market after the EUA is lifted
COVID-19 is and will continue to be the primary driver of new ways of doing business, exposing weaknesses in the global supply chain and forecasting for future operations. Join us by registering today.
Meet Your Presenter:
Ricki Chase is an executive director in the compliance practice at Lachman Consultant Services, Inc. As a global consultancy, Lachman and Ms. Chase provide expert consulting services to the pharmaceutical and life science industries throughout the world. She spent 20 years in public service, regulating pharmaceutical and medical devices at the state level and all FDA-regulated commodities at the federal level. Ms. Chase has experience from being an FDA investigator, directly inspecting regulated industry to director of investigations in the Chicago District, U.S. FDA, where she formed decisions on regulatory outcomes, investigations and inspections. Mrs. Chase also led FDA efforts in the Office of Emergency Operations and importation. While at Lachman Consultants, Ms. Chase has led both small and large remediation and quality system improvement projects and helped clients navigate inspections and responses to FDA findings and actions.
Who Will Benefit:
Decisionmakers within pharmaceutical companies:
- Regulatory Professionals
- Quality Professionals