Industry Events

WORKSHOP, SYMPOSIUM and CONFERENCE PRESENTATIONS

Dr. Motola is your consultant for Regulatory Affairs, Drug Development and Product Compliance. She is a frequent contributor to Industry Events, including the following:

  • Navigating the Orphan Drug Regulatory Process, May 2012, GLG Webcast, sponsored by Gerson Lehrman Group Inc.
  • How to Get Your Newly Discovered Drug Candidate into Human Clinical Trials in the US, June 2009, eLearning Webinar, sponsored by American Association of Pharmaceutical Scientists (AAPS).
  • Drug Development Benefit/Risk Assessment and Global Regulatory Strategy, March 2004, presented at Drug Development: Challenges and Strategies in Regulatory Affairs, Bethesda, MD, sponsored by the Drug Information Association (DIA).
  • Follow-On Biologics, July 2003, presented at Generic Drug Forum: Market Compliance Requirements, Philadelphia, PA, sponsored by Marcus Evans.
  • Developing Strategies which Facilitate Future Post Approval Changes, September 2001, presented at Post Approval Changes 2001, Philadelphia, PA, sponsored by Institute for International Research (IIR).
  • Optimizing Parallel Objectives: Building Relationships between Sponsors and FDA, July 2000, presented at Fast Track Drug Designation and Accelerated Approval Programs, Bethesda, MD, sponsored by Institute for International Research (IIR).

PANEL MEMBER, MODERATOR, CHAIR

  • The Regulatory 505(b)(2) Process, February 2013, May 2014; Breakout Session Table Leader, Conducted at MA CRO/CMO Symposium, Sponsored by Massachusetts Biotechnology Council, Boston, MA.
  • Regulatory Best Practices for Emerging Companies and First-Time Filers, June 2008, breakout session conducted at 2008 BIO International Conference (panel member).
  • Characterization and Comparability Issues for Changes in Cell Lines During Development and Post Approval Lifecycle of Therapeutic Biologics, June 2006, presented at 2006 National Biotechnology Conference, Boston, MA, sponsored by (AAPS); (organizer, moderator, panel member).
  • Proving Therapeutic Equivalence of Follow-On Biologics: How, When and Where?, 2005 National Biotechnology Conference, June 2005, San Francisco, CA, sponsored by American Association of Pharmaceutical Scientists (AAPS); panel member, moderator.
  • Current Issues and Challenges for Establishing Therapeutically Equivalent Biotechnology-Derived Products — The Age of Biogenerics?, 2004 National Biotechnology Conference, May 2004, Boston, MA, sponsored by American Association of Pharmaceutical Scientists (AAPS); moderator.
  • Drug Development Benefit/Risk Assessment and Global Regulatory Strategy, March 2004, Drug Development: Challenges and Strategies in Regulatory Affairs, Bethesda, MD, sponsored by the Drug Information Association (DIA); organizer/chair.
  • Generic Drug Forum: Market Compliance Requirements, July 2003, Philadelphia, PA, sponsored by Marcus Evans; panel member.

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