Individual Modules Regulatory Affairs

List of individual modules in Regulatory Affairs

Public Affairs Seminar

1 June 2012:

Sådan påvirkes og samarbejdes med forskellige interessenter af relevans for lægemiddelindustrien » Read more

Exam: Medicademy Module R1: The Pharmaceutical Law Frames in the EU

12 June 2012:

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Medicademy Module R2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation

5 September 2012:

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Introduktion til lægemiddelregistrering

13 September 2012:

Vil du gerne vide mere om lægemiddelregistrering og -lovgivning i EU? Dette kursus hjælper dig til at forstå registreringsansøgninger og procedurer, vedligeholdelse af godkendte lægemidler og en registreringsafdelings mange opgaver. » Read more

Hot Topic Seminar - Latest News within the Pharmacovigilance Legislation

21 September 2012:

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Exam: Medicademy Module R2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation

8 October 2012:

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Medicademy Module R12: Medical Devices - Drug/Device Combinations

9 October 2012:

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Medicademy Module R15: The Regulatory Affairs Environment for Generic Products in the EU

7 November 2012:

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Personal Workflow

13 November 2012:

Are you pinned down by long and stressful workdays? Have you lost track of all your commitments? Do you want to accomplish more and work less? Then this course is what you need to regain focus and energy. » Read more

Exam: Medicademy Module R10: Biopharmaceuticals - Quality Development and Documentation

12 March 2013:

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Medicademy Module R3: The Regulatory Affairs Environment in the USA

10 April 2013:

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Exam: Medicademy Module R13: The Regulatory Environment in Major Markets outside ICH - How you can optimise your regulatory strategy dealing with the BRIC Countries (Brazil, Russia, India and China)?

2 September 2013:

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Medicademy Module R7: Non-clinical Development and Documentation

6 November 2013:

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