CDER’s Priorities for 2022: What You Must Know About New Guidance and Program Plans – Webinar Recording/Transcript
Product Details
To comply in 2022 and beyond, you 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 presentation led by a former CDER official so you can stay compliant.
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 you stay ahead by focusing on the agency’s guidance schedule, 2022 Data Standards Program Action Plan and its Safe Use Initiative.
She’ll cover CDER’s latest thinking on drug regulation and enforcement as well as its outreach efforts to the pharmaceutical industry, including recent approvals, training programs, small business industry assistance and the state of affairs on operations — all of the things that factor into the FDA’s calculus in both its Office of New Drugs and Office of Generic Drugs.
Ms. Rajagopalan will discuss CDER’s ongoing activities to help address the national opioid crisis; its work to address unexpected — and potentially cancer-causing — impurities in medicines; and the use of a broad range of tools and technologies to transparently communicate drug safety to the public.
Gain insight into how to generate quality submissions, best communicate with the FDA and interpret the regulations.
Presentation Takeaways:
- Safety surveillance and oversight of marketed products
- Nitrosamine impurities in medicines and how 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 your attention and adherence
When you understand CDER’s thinking on its guidance and data standards documents, compliance is trouble-free. This expert-led presentation will get you there.
Meet Your Presenter
Radhika Rajagopalan, Ph.D., retired from the FDA’s Center for Drug Evaluation and Research (CDER) after almost 24 years of service in various capacities. She had served as an expert reviewer, held both a team leader position and an interdisciplinary position with the Office of Pharmaceutical Quality (OPQ), worked on policy issues involving lifecycle products and helped develop and implement ANDA Stability Guidance. She delivered five FDA guidances during her tenure and hired and mentored scores of reviewers within CDER’s OPQ. During her FDA tenure, Rajagopalan also served as a special assistant to the chemistry director. Prior to the FDA, she spent seven years in drug R&D, working for both Warner Lambert – Parke Davis division and Bristol Myers Squibb. She has contributed to writing portions of investigational new drug applications, supplemental applications and phase 3 clinical trial documents. Her experience over the years covers prescription drugs and prescription to over-the-counter switches.
Who Will Benefit
- Regulatory department staff
- R&D staff
- Technical writing staff
- Quality audit staff
- General scientists in the pharmaceutical industry