Every day challenges during the development and the registration of a drug are translated into practical solutions
.

Components

  • Domestic and foreign regulatory bodies: which ones are there, what authority do they have, how are they organised, what are the similarities and differences?
  • Different type of registration procedures for approval with FDA and Europe, what do they entail, what are the differences, lead time.
  • Government counselling procedure during development.
  • Regulations for clinical studies: where and how do you submit a request for approval of a clinical study.

Details

  • The language used for this module is English.
  • The above topics will be illustrated in detail, using real-life cases as examples.

Investment

€ 1.875,- including study materials, instructors, guidance for practical cases and/or role-playing games, catering (tea/coffee and lunch), and hotel (1x dinner, overnight accommodation, and breakfast).

Instructors/moderators
Instructors: Edna Venneker and Margot Amoureus (Afforce Healthcare BV).
Guest instructors: Marcella Brouwer, director regulatory affairs (Disphar); Pauline Walstra, Director Regulatory Affairs Europe (Astellas Pharma).

Location
Mundipharma BV, Leusden, The Netherlands

Date
2021

Apply
Applications are open. You can use the application form below. For further information, do not hesitate to contact us (phone +31(0)33-3034385 – email: contact@leergang-if.nl).