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Combining APIs: MPT Development & Regulatory Considerations
オンデマンド・ウェビナー

This third webinar in the “Let’s Talk MPTs” discussion series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active ingredients into an MPT product.

Speakers

Dr. Virna Schuck, PhD is Senior Director of Clinical Pharmacology at Certara and has over 16 years of experience in Pharmaceutical Development, working across the Discovery and Development phases. Throughout her professional career, Dr. Schuck’s work focused on integrating nonclinical and clinical data to drive clinical development strategies, dosing recommendations, and regulatory submissions.

Kevin Hershberger, MBA is Vice President of Integrated Drug Development at Certara and brings 20 years of experience in the pharmaceutical industry primarily in project leadership roles, and provides integrated program management (integrated plans, Target Product Profiles and financial planning. He has held leadership and management roles at Brighton Biotech, deCODE Genetics, Parke-Davis, Pfizer, and Takeda.

Dr. Tamra Goodrow, PhD, MSc is Regulatory Consultant & Principal at Deer Run Regulatory Consulting and has over 18 years of regulatory experience with global drug development, registration, and life cycle management in diverse therapeutic areas. Dr. Goodrow’s work includes the successful development of global regulatory strategy, as well as leadership of regulatory efforts resulting in the approval of multiple drugs.

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