MA-Applications
with emphasis on administrative processes and content of the dossier in module 1 |
- E-submission basics: terminology & background
- Generic and informed consent applications
- Well established use
- Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4)
- Line extensions
- 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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| Biological anti-infectives: Vaccines (active and passive immunization) |
- Definitions and particularities
- Legal basis for marketing authorisation (authorization procedures) and exemption from the obligation to obtain the marketing authorisation
- Access to investigational drugs during a public health emergency
- Specific aspects in the drug development, especially non-clinical and clinical development
- Influenza vaccines
- Live vectored vaccines
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| Blood products |
- Specific regulatory aspects for Blood components
- Specific requirements for marketing authorization of blood products (example coagulation factors)
- Plasma Master File
- Official Batch Release
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| Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products (Arzneimittel der besonderen Therapierichtungen) |
- Definitions
- Requirements (AMG, RL 2001/83/EC, 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 rules, MAA and registration procedure
- Anthroposophical products (brief introduction)
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| Veterinary products |
- Specifics for Veterinary Regulatory Affairs and Definitions
- Competent Authorities and Veterinary Legislation
- SmPC: VMP versus HMP
- Dossier Structure and Content
- Pharmacovigilance
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