ICH Q12: Post Approval Changes Management Protocols
Online Workshop
| No | Speakers Information | |
|---|---|---|
| 1 | Yoonjoo Park |
Director AHC(APEC Harmonization Center); Director NIFDS(National Institute of Food and Drug Safety Evaluation), Korea |
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Day 1 · Welcoming Remarks |
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| 2 | Azuana Ramli |
Deputy Director Centre of Product and Cosmetic Evaluation NPRA(National Pharmaceutical Regulatory Agency), Malaysia |
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Day 1 · Opening Remarks |
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| 3 | Sarah Pope Miksinski |
Executive Director CMC Policy, Advisory and Intelligence Gilead Sciences, United States |
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Day 1>Session 1 · Introduction of Life-cycle Management of Pharmaceutical Products and ICH Q12 concept· PACMP : Post-approval Change Management Protocol |
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| 4 | Andrew Chang |
Vice President Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Global Regulatory Affairs Novo Nordisk, United States |
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Day 1>Session 1 · Post Approval CMC Changes : How to Use ICH Q12 effectively |
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| 5 | Kyungnam Kim |
Novartis Certified GMP Auditor ATMPQA & Compliance Manager, Advanced Therapy Medical Product Norvatis Korea, Korea |
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Day 1>Session 1 · Pharmaceutical Quality Systems(PQS) and Change Management |
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| 6 | Jessica Lo Surdo |
Senior Manager Regulatory Affairs Amgen, United States |
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Day 1>Session 1 · Considerations & Strategic approaches for CMC |
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| 7 | Hugo Hamel |
Associate Director Centre for Blood, Blood Products and Biotherapeutics Health Canada, Canada |
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Day 2>Session 2 · Regulatory Perspectives· Panel discussion: PACMP Challenges & Recommendations |
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| 8 | Raphael Sanches Pereira |
Regulatory Expert and assistant Health Regulation and Surveillance Specialist ANVISA(Angencia Nacional de Vigilancia Sanitaria), Brazil |
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Day 2>Session 2 · Regulatory Perspectives· Panel discussion: PACMP Challenges & Recommendations |
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| 9 | Yasuhiro Kishioka |
Review Director Office of Cellular and Tissue-based Products PMDA(Pharmaceuticals and Medical devices Agency), Japan |
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Day 2>Session 2 · Regulatory Perspectives· Panel discussion: PACMP Challenges & Recommendations |
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| 10 | Mónica Perea-Vélez |
CMC Advocacy and Policy Director Global CMC Regulatory Affairs GSK, Belgium |
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Day 2>Session 2 · Industry Perspectives: Case 1 (GSK)· Panel discussion: PACMP Challenges & Recommendations |
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| 11 | Markus Goese |
Head EU CMC Regulatory Policy, Pharma Technical Regulatory Roche, Switzerland |
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Day 2>Session 2 · Industry Perspectives: Case 2 (Roche) |
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| 12 | Nina Cauchon |
Director Regulatory Affairs, Regulatory Affairs CMC Amgen, United States |
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Day 2>Session 2 · Moderator of Panel discussion: PACMP Challenges & Recommendations |
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| 13 | Connie S. Langer |
Regulatory CMC Strategist Pfizer, United States |
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Day 2>Session 2 · Panel discussion: PACMP Challenges & Recommendations |
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