Module 1 2021

30/06/2021

How to liaise options for dialogue National or EMA

 Scientific advice

• Early in development • can (and should) be repeated • national HA or EMA  Combined Scientific Advice with HTA • with EMA • possibilities on national level  Pre-submission meeting • first opportunity to meet product team

 Clarification meeting,  Oral explanation, SAG  Every Meeting to be prepared, attended and followed-up on as appropriate

The Organisation for Professionals in Regulatory Affairs

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 Examples of offers from National Authorities;  Medicines Evaluation Board, The Netherlands Alternatives for Early Dialogue Strategic Choice

• “Advies op maat”: personalised advice • Scientific Advice for small companies, • Primarily concerns pharmaceutical or pre-clinical aspects in early phases of development  Paul Ehrlich Institut, Germany ● Pre-Advice: – very early stage of development; – general (scientific) guidance and regulatory orientation – Informal exchange on general issues with regard to the medicinal product class;

The Organisation for Professionals in Regulatory Affairs

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