FDA Drug Topics Understanding Generic Narrow Therapeutic Index Drugs November 1, 2022
EIC – EMA Info Day: Regulatory support for the development of innovative medicines and technologies
Webinar on revision of the pharmaceutical legislation
The EMA perspective on drug approval process in the era of precision medicine
Drug Labeling Studies in Clinical Pharmacology: Recent FDA/EMA Updates
25 Years of EMA: building, learning and adapting to new challenges
FDA EMA immunogenicity guidelines APR2020
EMA multi stakeholder workshop on Qualification of novel methodologies - DAY I
How to Use a Reference Scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs
Comparison Between the Final US FDA, Japan PMDA, and EMA In Vitro DDI Guidance Documents...
Impact of Rare Disease Initiatives at EMA and Health Canada
EMA and EORTC soft tissue and bone sarcoma workshop
IPA programme – 1st training – Human products parallel session
S1 Overview of EMA-approved anti-cancer products
The European Medicines Agency and patient involvement in the drug approval process
Module 4. EU Paediatric Regulation & Authorisation of Medicinal Products
Biosimilars and Biologics
COMP Workshop Support for development of orphan medicines
Which medicines should be used in cancer care? by Nathan I Cherny, MBBS, FRACP, FRCP
Patient Reported Outcomes as endpoints in oncology trials and marketing claims: FDA/EMA perspective
