Resources
Home
/
Resources
-
Global Perspective on Regulatory Reliance
Speaker Presentation Azatyan Samvel World Health Organization (WHO) 2023 -
Could One Size Fit All- Why Not?
Speaker Presentation Ayer Kavita Seagen Inc. 2023
-
Extending a Commercial Specification Beyond the Clinically Qualified Limits, How to Overcome the Challenges
Speaker Presentation Auquier Vanessa UCB Pharma S.A. 2023
-
Specifications and Lifecycle Management
Speaker Presentation Ahern Theresa Eli Lilly & Co. 2023
-
CMC Strategy Forum Europe 2023 Scientific Program
Scientific Program: CMC Strategy Forum Europe 2023
-
CMC Strategy Forum Europe 2023 Summary Infographic
Summary Infographic: CMC Strategy Forum Europe 2023
-
EMA Perspectives on International Convergence and Collaboration for CMC Submissions
Speaker Presentation Kotzagiorgis Evangelos EMA 2023 -
Genesis of ICH M4Q: From Inception to the Present Day
Speaker Presentation Markovic Ingrid CBER FDA 2023
-
The Revision of Brazilian Guidelines for Post-Approval Changes and Stability, and Its Impact on International Convergence in the Regulation of Biotechnological Products
Speaker Presentation Tavares Neto João ANVISA 2023
-
Post Approval Change Management - Global Harmonization Perspectives
Speaker Presentation Abdellah Hanane Merck KGaA 2023
-
CMC Latin America Session III 2023 Scientific Program
Scientific Program: CMC Latin America Session III 2023
-
CGE - Becoming the CE Expert in Your Organization – Best Practices Exchange
Roundtable 2 Notes: CE Pharm 2023
-
Cell Therapy CE Applications
Roundtable 3 Notes: CE Pharm 2023
-
Unaddressed Challenges & Technical Innovations
Roundtable 9 Notes: CE Pharm 2023
-
Strategies-Instrument Bridging & Replacement Implementation
Roundtable 8 Notes: CE Pharm 2023
-
Peak Characterization - CGE, Peak Characterization CZE, Peak Characterization - CIEF
Roundtable 1 Notes: CE Pharm 2023
-
iCIEF - Becoming the CE Expert in Your Organization - Best Practices Exchange
Roundtable 2 Notes: CE Pharm 2023
-
How Can We Ensure Our CE Methods are QC Ready
Roundtable 4 Notes: CE Pharm 2023
-
Gene Therapies, Vaccine and AAV CE Applications
Roundtable 7 Notes: CE Pharm 2023
-
CE MS - Method Development Application and Implementation in Biopharmaceutical Development
Roundtable 5 Notes: CE Pharm 2023