Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects

• Date:
  Monday, 3 October 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This workshop aims to provide an overview of non-clinical data requirements for the authorisation of human medicinal products, how to address these during the medicinal product development, and detail the approaches for biological and advanced therapy medicinal products. A regulatory brief on the new PRIME scheme is also included in the programme.

Documents

Agenda - Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects

Reference Number: EMA/26126/2016

Presentation - Key aspects of non-clinical pharmacology and pharmacokinetics in the evaluation of safety (David R Jones)

Presentation - Pre-clinical requirements to support development of paediatric medicines (Janina Karres)

Presentation - Regulatory compliance in non-clinical development (Milton Bonelli)

Presentation - Approaches to the non-clinical development of advanced therapy medicinal products (Fernando Mà©ndez-Hermida)

Presentation - Considerations for the development of biological medicinal products (Camilla Svensson)

Presentation - Approaches to genotoxicity and carcinogenicity assessment (Peter Kasper)

Presentation - Reproductive toxicity: An introduction to regulatory aspects on detection of toxicity to reproduction for medicinal products (Gà¼nter Waxenecker)

Presentation - PRIME (Jordi Llinares and Zahra Hanaizi)

Multimedia