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Mentorship and Training at Mentorship and Training at PCWP PCWP PCWP the 13th of September Information/insights insights/ /wisdom wisdom Information/ Information: What is necessary to know? What could be learnt in 30


  1. Mentorship and Training at Mentorship and Training at PCWP PCWP PCWP the 13th of September

  2. Information/insights insights/ /wisdom wisdom Information/ Information:  ◦ What is necessary to know? ◦ What could be learnt in 30 min? ◦ What could be put on fact sheets for reference? Insights:  ◦ Through mentorship, other discussions and experience Wisdom – how to apply it all! 

  3. Mentorship within PCWP Mentorship within PCWP Informal set-up - 2 choices  A. Use info on web with informal talks  and fact sheets of choice B. Watch 30 min. webinar, and 5 fact  sheets and informal talks ◦ Fact sheets: Pathway of drugs(ped./orphan, ordinary) ◦ Overview of how it is linked together - the EC, EMA and its Committees, Working Parties, SAGs, SAWP, the PCWP ◦ The PCWP – info and lists of activities

  4. Suggested extra modules modules of Suggested extra of training in November training in November Pathways for drugs in EMA -From a  potential drug/wish to make a market application by a pharma company - to a centrally approved drug Overview of how it is linked together -  the EC, EMA and its Committees, Working Parties, SAGs, SAWP, the PCWP Best Practise session – how to improve  and increase interaction with EMA eg. coaching patient experts

  5. Information to patients coming coming Information to patients once only once only Information:  ◦ What is necessary to know? ◦ What could be learnt in 30 min? ◦ What could be put on fact sheets for reference? Travel and accomodation, procedures at EMA  Info sheet from the organisation  Letter to patient expert  Info on the drug pathway 

  6. Suggestion – – to have have Patient Suggestion to Patient experts’ ’ testimonials on the web web experts testimonials on the 1. Why did I go to the EMA?  2. What was expected from me?  3. How much notice did I get?  4. How did I prepare?  5. What was it like? Describe the  experience. In which language was it? 6. Was there any difficulties?  7.Did I get any feedback?  8. Any other thoughts on the matter? 

  7. Training on the 29th of Nov. Training on the 29th of Nov. Send new ones!?  Make sure that EMA-literacy is shared  within the organisation --------------------------------------------------- Half-day with new modules  Evaluate and summarize the training by  working in groups at the end of the day More hands on – looking at the PL and  looking both at the structure and contents at the same time

  8. Welcome in November! Welcome in November!

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