CRED+ Optimising Interactions With Regulators - Slides

Optimising Interactions with Regulators: Information for Participants

Dear Participant of our Workshop,

You know from the advertisement of the Workshop that it will be highly interactive and that you can have your own case studies and questions reviewed by regulatory experts. For the Workshop to be efficient and effective, we provide you in advance with the following information • Document Explanatory remarks for the Practical Skill Developments (PSD) • Information for 6 PSDs • Powerpoint presentation Introductory Discussion

These documents you should definitely have read when coming to the course. You will have the choice, which of the PSDs we will exercise during the course.

In addition to the a.m. documents, we provide you with • a Powerpoint presentation Guidance for Interactions, which may be worth looking at upfront • Frequently used Abbreviations (containing more than we will need in the course) • References containing information on guidance on meetings or interactions with Health Authorities in the EU and US

Last, but not least - don’t forget to bring your own cases!

We are looking forward to meeting you and to an exciting Workshop!

Gabi, Otmar and Truus

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