Putting the Pieces in Place to Support IND Submissions — and an IPO
Drug discovery, development, and commercialization is like a puzzle. The end may be easy to visualize, but there are many pieces that need to be…
Integrated Project Management Company, Inc. (IPM) is proud to announce that seven of its pharmaceutical, medical device, and biotech regulatory experts will share their knowledge and experience at the RAPS Convergence 2020 conference.
The subject matter experts are participating in five educational sessions, which were selected from among more than 300 abstract submissions.
The Secrets of Creating an Effective Regulatory Strategy and Avoiding Disastrous Mistakes
Principal Consultant Susan Carino will share the virtual stage with Daniela Drago, Senior Director, Regulatory Sciences, Biogen, and Fred Senatore, Medical Officer, Office of New Drugs, CDER, FDA, where they will discuss key factors to consider and pitfalls to avoid when developing a global regulatory strategy.
Don’t Let a Crisis Become a Disaster
Senior Project Management Consultants Patricia Reardon and Eric Hill will walk through a step-by-step approach to planning for and handling warning letters, product quality issues, and other crises, to minimize their impact on the organization.
Leadership Insights for Regulatory Professionals – Personal Brand Management
Senior Project Management Consultant Ruba Hadidi will present an interactive session aimed at helping attendees expand their leadership skills and take control of how they are perceived.
Regulatory Insights Throughout the Commercialization Realm and Product Life Cycle
Paul Cook, IPM’s Director of Business Development – Life Sciences, will moderate a discussion on the partnership between the regulatory and commercialization teams with the panelists listed below.
- Eyal Golan, Senior Project Management Consultant, IPM
- Tammy Phinney, Senior Vice President, Regulatory Affairs, Sage Therapeutics
- Tina Purcell, Associate Director, MSL – Oncology, Astellas Pharma
- Janaki M. Subramanyam, Executive Director, Regulatory Affairs, Allena Pharmaceuticals, Inc.
- Joanne Totosy de Zepetnek, Vice President, Regulatory Affairs, Rhythm Pharmaceuticals
Solution Circle: Parallel Global Submissions: Navigating the Space Between Submission and Approval
Senior Project Management Consultant Darwin Keith-Lucas will moderate an informal discussion with an intimate group of attendees to share ideas and experiences around complex regulatory submissions.
The RAPS Convergence conference is scheduled to take place September 13-16 in a virtual format. Every year, the event brings together medical device, pharmaceutical, and biotech professionals from around the world to discuss current regulatory issues in the healthcare products industry. Presented by the Regulatory Affairs Professionals Society, the conference is the largest annual gathering of regulatory professionals.
— Published July 20, 2020