Health

CDER’s Priorities for 2022, What You Must Know About New Guidance and Program Plans Webinar on May 17, 2022

Leave a comment



FALLS CHURCH, Va. (PRWEB)

CDER’s Priorities for 2022:

What You Must Know About New Guidance and Program Plans

An FDAnews Webinar

Tuesday, May 17, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/cder-priorities-for-2022

To comply in 2022 and beyond, drugmakers need to understand the most recent guidance and data standards from the FDA’s Center for Drug Evaluation and Research (CDER).

Get up to date on the agency’s top priorities with this webinar led by a former CDER official.

Radhika Rajagopalan, Ph.D., a consultant with EAS Consulting Group who has nearly 24 years of service in CDER’s Office of Pharmaceutical Quality (OPQ), will ensure drug professionals stay ahead by focusing on the agency’s guidance schedule, 2022 Data Standards Program Action Plan and its Safe Use Initiative.

Radhika will cover CDER’s latest thinking on drug regulation and enforcement as well as its outreach efforts to the pharmaceutical industry.

Whether the focus is on new drugs or generics, this webinar will provide insight into how to generate quality submissions, best communicate with the FDA and interpret the regulations, including:


  • Safety surveillance and oversight of marketed products

  • Nitrosamine impurities in medicines and how the FDA is continuing its response

  • Continued efforts to address the misuse of opioid drugs and controlled substances

  • Ensuring quality, effectiveness, and safety of new and generic drugs

  • What data standards need attention and adherence

When drugmakers understand CDER’s thinking on its guidance and data standards documents, compliance is trouble-free. Get there with this expert-led webinar.

Webinar Details:

CDER’s Priorities for 2022:

What You Must Know About New Guidance and Program Plans

An FDAnews Webinar

Tuesday, May 17, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/cder-priorities-for-2022

Tuition:

$287 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/cder-priorities-for-2022

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.

Share article on social media or email:

Leave a Reply