Method of examination: Course work
Credit points: 5

Module Head: Dr. Christine Mayer-Nicolai

1	Abridged / Generic Applications with emphasis on administrative processes and content of the dossier in module 1  Essentially similar and informed consent applications Bibliographical Application Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4) Line-extensions Scientific Advice at the BfArM The marketing authorization application form Exercise on the application form
2	National applications at BfArM (Pr�fung nationaler Zulassungsantr�ge im BfArM) Assessment process, e.g. efficacy (Wirksamkeitspr�fung) Clinical Trial reports according to Annex one of Directive 2001/83, Clinical Summary and Overview, relevant aspects in the assessment of clinical part of the dossier, fixed combinations Summary of Product Characteristics (SmPC) Company Core Data Sheet Package leaflet and consultation with target patient groups Labelling (Kennzeichnung) Specific BfArM requirements (Besonderheiten in den Anforderungen des BfArM und zugeh�rige Bekanntmachungen) Labelling principles in national phases of EU procedures
3	Veterinary products  Definitions Veterinary Legislation in Germany, EU and globally EMEA, CVMP, HMA and CMD(v), VICH, Animal Health Industry Associations Specific aspects of the SmPC Parts of a Dossier - Part I, II, IIIA Safety, IIIB Residues, IV Withdrawal Periods Ecotoxicity
4	Vaccines Definitions and specific aspects Combinations Influenza vaccines Authorization procedure (brief introduction) Vaccine Antigen Master File (VAMF)
5	Advanced Therapies Relevant Directives, Regulations, Guidelines Definition and classification: advanced therapy medicinal products, tissue products, combined products Authorization procedures Incentives
6	Blood products Specific regulatory aspects for Blood components Official Batch Release Specific requirements for marketing authorization of blood products (example coagulation factors) Plasma Master File Exercise on blood products
7	Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (Arzneimittel der besonderen Therapierichtungen) Definitions Requirements (AMG, AMPr�fRL, pharmacopoeas) Possible MAA/registration procedures and required data on S, Q, E Herbal medicinal products, HMPWP, Botanical nomenclature, Extracts (labeling) Homeopathic medicinal products: The homeopathic principle, manufacturing according to PhEur Registration procedure Anthroposophical products (brief introduction)