Resources
Home
/
Resources
-
Navigating the CMC and Regulatory Challenges of a Breakthrough Therapy Product for Multiple Myeloma
Speaker Presentation Schaefer Gene Janssen R&D, LLC 2019 -
Leveraging Innovation to Improve Patient Access & Global Health
Speaker Presentation Robinson David The Bill & Melinda Gates Foundation 2019
-
Process Science to Regulatory Science: Control Strategy and Established Conditions 2019
Speaker Presentation Robbins David MedImmune, A member of the AstraZeneca Group 2019
-
Biologics in Brazil: Overview and Perspectives on Harmonization
Speaker Presentation Rama Elkiane ANVISA 2019
-
Access-by-Design:
Making Biologics Available to All
Speaker Presentation Ram Rajeev MIT and Springs Stacy MIT 2019
-
The Role of the Biological Laboratory in the Regulation of the Quality of Biological Products
Speaker Presentation Pines Gilia Israeli Ministry of Health 2019
-
African Medicines Regulatory Harmonization - AMRH: Current Trends
Speaker Presentation Owusu-Danso Patrick Food and Drug Authority, Ghana 2019
-
PMDA Updates with a Focus on GMP/CMC
Speaker Presentation Nakashima Nobu PMDA-Pharmaceuticals and Medical Devices Agency 2019
-
Performance Based Approaches an Enabler
for Process Analytical Technology (PAT)
Speaker Presentation Moore Christine Merck & Co., Inc. 2019
-
Health Canada’s Participation at ICH &Considering ICH-Q12 Implementation
Speaker Presentation Lourenco Celia Health Canada 2019
-
Mapping Future Technology Needs and Prioritization of Critical Quality Attributes for Enabling In-Line Monitoring and Real Time Release Testing
Speaker Presentation Loladze Vaho GlaxoSmithKline 2019
-
WHO Standards for Biotherapeutics: Tools for Regulatory Convergence
Speaker Presentation Knezevic Invana World Health Organization (WHO) 2019
-
Improving Patient Access & Public Health: How Global Health Authorities and Industry can Collaborate on CMC Expectations
Speaker Presentation Karikari-Boateng Eric Food and Drug Authority, Ghana 2019
-
An Advanced Process Control Framing to Application of Analytics and Modeling for Biopharm Manufacturing
Speaker Presentation Guenard Robert Biogen 2019
-
Biosimilar Regulation in Israel
Speaker Presentation BenNaim Vered Israeli Ministry of Health 2019
-
Unsupervised Machine Learning for Improved Understanding, Optimization, and Process Monitoring, Fault Diagnosis in Early Development
Speaker Presentation Afanador Nelson Merck & Co., Inc. 2019
-
Extractables and Leachables- What’s Being Requested and What’s Everyone Doing?
Roundtable 29 Notes: WCBP 2020
-
Formulation Development
Roundtable 28 Notes: WCBP 2020
-
Shipping Studies – Analytical Strategies
Roundtable 27 Notes: WCBP 2020
-
Data Integrity
Roundtable 26 Notes: WCBP 2020