The most valued regulatory professionals are more than technically competent. They have multiple regulatory voices depending on the situation—team member, leader and facilitator—especially across a wide array of health authority, compliance, cultural, ego, cross-functional and developmental issues.
Learn the professional development skills you need for success, including how to advance these critical skills and how to improve the power of your regulatory voices strategically. This will be discussed in the context of the various roles regulatory professionals play in different scenarios, teams and companies.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able to:
- Ensure regulatory voices are heard at the strategy table
- Encourage regulatory to take a more assertive role at health authority meetings
- Anticipate and prepare for issues, addressing them persuasively
- Manage cross-functional teams
Who Should Attend?
- Regulatory practitioners who want to develop performance improvement plans
- Regulatory professionals who want to develop a path to management
- Regulatory managers
- Regulatory career path prospects
Michael J. Vivion, PhD, principal, ECG Inc.
Michael J. Vivion, PhD, has a long record of success in dealing with regulatory agencies in the US, Canada, Europe, Japan and China on behalf of both new and existing pharmaceuticals, devices, biologics and vaccine products. Previously, Vivion was global head of strategic communications for F. Hoffmann-La Roche in Basel. He worked with numerous teams to help develop communication strategies and tactics in therapeutic areas ranging from HIV to oncology and allergies to obesity. Vivion continues his appointment as a visiting lecturer on regulatory communication for the European Centre of Pharmaceutical Medicine at the University of Basel. He is also a frequent speaker at major business and university conferences.
Beth Weinberg, RPh, advisor—global regulatory affairs—North America, Eli Lilly and Company
Beth Weinberg has held various roles at Eli Lilly and Company during her 20 year career including clinical, scientific communications and in advertising/promotion and development regulatory affairs. She has worked across many therapeutic areas and currently focuses on diabetes drugs in development.
Weinberg has supported both marketed products and drugs in development and has successfully managed key New Drug Application (NDA) supplements, including labeling, Chemistry, Manufacturing and Controls (CMC) and 505(b)(2) applications. Previously, Weinberg worked as an executive sales representative for Abbott Laboratories.
Jacques C. Mascaro, senior vice president, global regulatory affairs and R&D quality assurance, Merck Serono
Jacques C. Mascaro, Phd, has a long history in regulatory. One of his professional passions is providing regulatory professionals the tools and skills to do their jobs successfully. In 2012, Mascaro became senior vice president global regulatory affairs & quality assurance at Merck Serono, and has been acting head of global clinical development since 2014. He has served in a similar regulatory affairs capacity at H. Lundbeck A/S (DK), European R&D Headquarters of Johnson & Johnson PRD (UK), F. Hoffmann-La Roche at the Basel Headquarters and at Elan. He has worked in the specific areas of Multiple Sclerosis, oncology, neurology, hematology and Alzheimer’s disease. Mascaro holds a PhD in lipoproteins and a post-doctorate diploma of superior specialized studies in clinical pharmacy from the University of Aix-Marseille II and an MBA from the Open University Business School.
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