FDAnews Announces — Post-Pandemic Pharmaceutical Regulations: COVID-19’s Impact on Drug Approvals and Postmarket Surveillance Webinar Aug. 5, 2020

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COVID-19 upended the pharma supply chain, with global regulators making far-reaching changes — here’s how to move forward.

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WCG FDANews

COVID-19 upended the pharma supply chain, with global regulators making far-reaching changes — here’s how to move forward.

Post-Pandemic Pharmaceutical Regulations:
COVID-19’s Impact on Drug Approvals and Postmarket Surveillance
An FDAnews Webinar
Wednesday, Aug. 5, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/pharmareg

The pandemic has disrupted everything, from the global pharmaceutical supply chain to drug approvals and postmarket surveillance. 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. FDA and industry players are making long-term changes to how they think about and execute business objectives.

Ricki Chase will help attendees manage the current state by explaining where things are and what one 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.

She will explain:

  • 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.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:
Post-Pandemic Pharmaceutical Regulations:
COVID-19’s Impact on Drug Approvals and Postmarket Surveillance
An FDAnews Webinar
Wednesday, Aug. 5, 2020, 1:30 p.m.-3:00 p.m. EDT
https://www.fdanews.com/pharmareg

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/pharmareg
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDAnews
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