Join Sidley for a two-day program designed to provide a sophisticated, comprehensive foundation in regulatory law for in-house lawyers involved in biopharma development, manufacturing, and marketing. Whether you are relatively new to regulatory counseling and risk mitigation or more experienced counsel looking for an efficient way to catch up on developments in the law from the past two years, this event is for you. By the end of the second day, you’ll have the information and insights you need to tackle any biopharma regulatory issue and know when to worry, whom to call, and how and when to scale up.
- Learn from Sidley’s most experienced biopharmaceutical regulatory lawyers and head back to work with high-quality substantive materials to make your job easier.
- Get to know your instructors and peers during breaks and over dinner — networking is risk management.
- Come as you are — we will provide the conditions you need for a comfortable, productive learning experience, from an on-demand barista to comfortable seating, great tech, and high-end supplies.
- If need be, catch up on work in our newly refurbished, sunny, spacious break-out rooms.
Click here to view the full agenda.
Wednesday, May 18, 2022
- Drug Development — Clinical Trials, Biostatistics, Real-World Evidence, and Disputes
- Ethics — Ethics Issues Arising in FDA Regulatory Contexts
- Statutory Exclusivities
- AKS/Fraud & Abuse
Thursday, May 19, 2022
- Supply Chain Essentials — DSCSA, PDMA, GMP
- Public Company Disclosure Issues — Regulatory and Enforcement (FDA and SEC), Class Actions
- Ethics Issues Arising in FDA Regulatory Contexts
WHO SHOULD ATTEND
In-house counsel with responsibility for regulatory compliance, analysis, engagement, and risk mitigation.
CLE credit for this program is pending.
For more information, contact email@example.com.