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CMC Strategy Forum Latin America

'Reliance' on Inspections: Not Just a Buzzword but a Real Opportunity

Speaker Presentation Raviol Holger, F. Hoffmann La Roche Ltd., 2021
Accelerated Technology Transfer to Meet Demand for a Repurposed Biologic: Challenges, Successes and Lessons Learned

Speaker Presentation Raviol Holger, F. Hoffmann La Roche Ltd., 2021
Regulatory Issues in the Context of Health Emergencies - Learnings and Recommendations

Speaker Presentation Lumsden Rebecca, Pfizer Limited, 2021
Expedited Product Development: Application of Regulatory Lessons Learned

Speaker Presentation Levis Robin, CBER, FDA, 2021
RBD-specific Polyclonal F(ab')2 Fragments of Equine Antibodies Improve Survival in Severe Patients Hospitalized with COVID-19

Speaker Presentation Goldbaum Fernando, Inmunova S.A., 2021
Pandemic Preparedness: Regulatory Agility in the Era of COVID-19 - Latin America

Speaker Presentation Fernandes Jason, Health Canada, 2021
Regulatory Perspectives on the Accelerated Development of Bamlanivimab - a SARS-CoV-2 Neutralizing Antibody

Speaker Presentation Dobbins JR, Eli Lilly and Company, 2021
Reliance, Virtual Inspections and Regulations - Brazilian Strategies During COVID-19 Pandemic

Speaker Presentation Ihatanderson Alves da Silva, ANVISA-National Health Surveillance Agency, 2021
More Structured, Interactive Process to Drive Convergence in Latin America Advocated by Biotech Product Regulators and Industry at CMC Strategy Forum in Brasilia

CMC Summary Paper: CMC Strategy Forum Latin America 2015

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