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Session 5-6: Innovative Medicines and its CMC Regulatory Challenges
Session Chair(s)
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
The session will provide some insights on specific CMC challenges and opportunities for novel technologies such as gene therapy, radioligand therapies and oligomers. Considering high expectation from patients around the world for such innovative treatments to address unmet medical needs there is an urgent need for global approaches to drive for global regulatory requirements using the appropriate science and risk-based tools to address the CMC challenges. Industry will illustrate regulatory filings strategies considering the complexity for such type of medicines which will be discussed with regulators from different jurisdictions.
Speaker(s)
Gene Therapies
Adam Walker, PhD
GlaxoSmithKline, United Kingdom
Director, Biopharm CMC Global Regulatory Affairs
Radio-Ligand Therapy: Is it a New Emerging Platform that Needs Specialized Regulations?
Camelia Cercel
Advanced Accelerator Applications, a Novartis company, Switzerland
Global Head Regulatory CMC
Radio-Ligand Therapy: Is it a New Emerging Platform that Needs Specialized Regulations?
Jordi Vall-llossera
Advanced Accelerator Applications, a Novartis company, Switzerland
Global Head of Quality
Oligonucleotides (siRNA & others)
Susanne Kindermann, PhD
Roche, Switzerland
Group Lead Development Small Molecules, Technical Regulatory
ICH Quality Discussion Groups
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Panel discussion with Q&A, with the additional participation of:
Evangelos Kotzagiorgis, MPharm, MS
EMA, Netherlands
Pharmaceutical Quality Senior Specialist, Pharmaceutical Quality Office, Human M
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