*for whole course attendees there is one additional day, Saturday, for group work and exam

*for whole course attendees there is one additional day, Saturday, for group work and exam

1. The European Pharmaceutical Legislation
2. The Regulatory Institutions and other stakeholders
3. Interaction of international Agencies
4. The general requirements for the Common Technical Document (CTD), the Marketing Authorisation Dossier (Module 1, Module 2)
5. Special legal provisions for biopharmaceuticals
6. Orphan Drug Designation
7. SME
8. Principles of registration and certification of medical devices and device/drug combinations

1. Clinical trial applications
2. Marketing authorisations
3. Variations

in the EU, USA, Japan, Switzerland and China

1. Registration of blood products and the use of the Plasma Master File
2. Development and regulation of vaccines
3. Case Study: Approval of HPV vaccines in the EU
4. ATMPs

1. Sources and main characteristics of biopharmaceuticals
2. European CMC data requirements for the marketing authorization (Module 3) and for the IMP
3. Comparability
4. Formulation development
5. Isoform characterization and glycosylation of biopharmaceuticals
6. Virus and TSE safety
7. Stability of biopharmaceuticals
8. Bioassay establishment and data presentation
9. New approaches in the manufacture - platform technologies and QbD
10. CMC Data requirements in the USA and Japan
11. The special characteristics of the International Nonproprietary Name system (INN) for biopharmaceuticals

1. Principles of non-clinical development
2. Principles of clinical development
3. Immunogenicity
4. Case studies on monoclonal antibodies, erythropoietin and a biosimilar
5. Case presentation on the tri-functional monoclonal antibody Catumaxomab
6. Development and registration of biosimilars

1. Background of development and content of the paediatric Regulation No 1901/2006 EC
2. Implementation of the Paediatric Regulation and Commission PIP guideline
3. Considerations for developing and executing the PIP
4. Implications of the EU legislation for the pharmaceutical industry: Perspectives, Challenges and Opportunities

1. Pharmacovigilance concepts and specific aspects relevant to biologicals
2. Legal requirements and safety deliverables
3. Regulatory expectations
4. Risk management approach
5. Operational Aspects – PhV system, business processes, project management, quality oversight, safety governance models, audits and inspections

1. Principles and underlying legislation for the establishment of GMP, GLP, GCP
2. GMP authorization –procedures in the EU and requirements for third countries
3. The supervising authorities – Role of national inspectorates and EMA
4. Experience with GMP-inspections by inspectorates from USA, EU, Japan
5. Compliance and steady optimisation of production and processes
6. Role of EDQM and OMCLs
7. Certificates of suitability
8. The PIC-S and WHO
9. The Rapid Alert System
10. Counterfeits

1. Regulatory strategy and global positioning of newly developed and existing products
2. Pre-marketing interactions with regulatory agencies: scientific advice and pre-IND procedures
3. Concepts and tools to support regulatory processes
4. Regulatory strategy for the introduction of changes in the manufacturing process
5. Intellectual Property Rights
6. Health Technology Assessment

1. Good regulatory practice
2. Function, skills and performance of a regulatory affairs professional
3. Cross-functional communications and interaction
4. Agency meetings in practise
5. Project management, time lines
6. Data and document management
7. Tools for daily practise and conferences to attend