| Regulatory Intelligence |
Abridged / Generic Applications
with emphasis on administrative processes and content of the dossier in module 1 |
- Essentially similarGeneric and informed consent applications
- Bibliographical applications Well established use
- 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
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| Product Information Management |
- 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
- Assessment process, e.g. efficacy (Wirksamkeitsprüfung)
- Company Core Data Sheet
- Summary of Product Characteristics (SmPC)
- Package leaflet and consultation with target patient groups
- Labelling (Kennzeichnung)
- Labelling principles in national phases of EU procedures
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| Advanced Therapies |
- Relevant Directives, Regulations, Guidelines
- Definition and classification: advanced therapy medicinal products, tissue products, combined products
- Authorization procedures
- Incentives
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| Vaccines |
- Definitions and specific aspects
- Combinations
- Influenza vaccines
- Authorization procedure (brief introduction)
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| 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
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| Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (Arzneimittel der besonderen Therapierichtungen) |
- Definitions
- Requirements (AMG, AMPrüfRL, 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)
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| Veterinary products |
- Specifics for Veterinary Regulatory Affairs and DefinitionsDefinitions, Veterinary Legislation in Germany, EU and globally
- Competent Authorities and Veterinary LegislationEMEA, CVMP, HMA and CMD(v), VICH, Animal Health Industry Associations
- SmPC: VMP versus HMPSpecific aspects of the SmPC
- Dossier Structure and ContentParts of a Dossier - Part I, II, IIIA Safety, IIIB Residues, IV
- Withdrawal PeriodsPharmacovigilance
- New EU Regulation on Veterinary Medicinal ProductsEcotoxicity
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