Planning for success: When and how to develop a regulatory roadmap

Regulatory approval is a major inflection point and value driver for companies, yet many wait too long to plan and develop a roadmap for success. In this workshop you will learn about:

• The overall regulatory process
• What steps to take and when to take them
• Documentation and quality systems
• What to look for in hiring regulatory expertise

Our speakers have first-hand experience and expertise in all phases of the regulatory process for drugs and IVD/devices. Regardless of the stage of your company, you will gain valuable knowledge and insights. Join us for an informative discussion.

Speakers

Jennifer Grodberg, Sr. Vice President, Regulatory Affairs and Program Management, Forge Therapeutics

Luis Jimenez, Vice President, Business Development, Brandwood Biomedical

Michael Monahan, Sr. Director, Regulatory Affairs and Quality Assurance, Crinetics Pharmaceuticals

Agenda:

5:30pm –  6:00 pm Networking and light refreshments

6:00pm –  7:30 pm Presentations and Q & A

7:30pm –  8:30 pm Breakout Sessions with individual speakers / discussion & networking

$30 SDEE & HeraHub Members

$50 Non-members