Module
Clinical and pre-clinical development

Clinical and pre-clinical development is a strategic process from start to finish. What phase does the developer want to reach? What needs to happen to reach this phase, and what financial provisions does it require? Are there any potential pitfalls? How do you avoid them? What partners do you need, and when?

Components

  • Clinical and pre-clinical development: target product profile, what is it, and why is it important.
  • Pre-clinical development: types of studies, which studies in which phase of development, interpreting results.
  • Pre-clinical development: study medicines requirements and project development stage for the various phases.
  • Clinical development: types of studies, study design, strategic thinking in clinical development.
  • Clinical development: new entities, orphan medicines, generic medicines, biosimilars and OTC.
  • Clinical development: study medicines requirements and project development stage for the various phases.
  • Clinical development: ethical aspects, organisation and logistics of medicines research & study medicines, frequently used tools for the organisation/logistics of clinical studies.
  • Pharmacovigilance.

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).

Location
Not known yet.

Date
Not known yet.

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).

Details/extras

  • Participants will develop cases in small groups, and subsequently present them to the whole group.
  • Given the content of the module, a company visit is not part of the programme.
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