DIA: Driving Insights to Action
Science:Life Sciences
Dr. Moheb M. Nasr, who serves as Vice President, CMC Regulatory Strategy for GlaxoSmithKline, is a member and rapporteur of the Expert Working Group for the ICH Q12 Guideline, Technical and Regulatory Considerations for the Pharmaceutical Product Lifecycle. “We realized that the ICH 8 through ICH 11 Guidelines were mostly on the development stage of the life cycle, and there is a gap that needs to address the commercial phase of the life cycle,” he explains in this exclusive Global Forum podcast. “Hence, there was an agreement to develop an ICH Q12 to address this gap and in particular to develop a roadmap to facilitate the management, from the technical, commercial, and regulatory perspectives, of the life cycle.” Dr. Nasr also serves on the program committee for DIA’s 2017 CMC Workshop, where he will co-chair the session that further explains the Benefits and Challenges of ICH Q12 Life Cycle Management. Register to attend the DIA 2017 CMC Workshop!
DIAmond Session 203: “Innovation is Clearly Happening”: Next Generation Collaboration: Transforming the Industry
DIAmond Session 201: International Regulatory Convergence, Collaboration & Cooperation
Executive FDA Leadership Reviews & Previews PDUFA Reauthorization
“Biosimilars have at last come of age in the United States”
Mission, History & Opportunity Attracts New DIA Americas Leadership
Clinical & Real-World Data: Is AI the Missing Link?
TransCelerate Moves Clinical QMS from Vision to Conceptual Framework
Executive Director Shares New CTTI Strategic Plan to Improve Clinical Trials
Who Determines the Price of Medicines – and How?
“An Urgent Imperative Now to Learn Quickly”: DIA 2016 Co-Chair Dr. Gigi Hirsch
Industry-Patient Relations: Culture Change or Culture Shock?
Every Journey Begins with a First Step: DIA Patient Engagement
“Outbreaks are inevitable. Pandemics are preventable.” – DIA 2016 Keynote Speaker Dr. Larry Brilliant
Growing Irrelevancy of Pre- versus Post-Market Divide for EU Medical Devices
Crossroads in Europe: Access from a Market and HTA Perspective
A Visionary Takes the Helm at DIA Europe, Middle East & Africa (DIA EMEA)
Steps to Meet the “Big Quality” Challenge of “Big Data”
Innovation: Can it Span the “Efficacy versus Effectiveness Gap”?
Dr. Kemal Malik Ponders “Is Innovation Always the Answer?”
EMA Senior Medical Officer Explains “Access versus Evidence Tradeoff”
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