GMP & GCP 2012 - International Summit on GMP & GCP: USA, Europe, Japan, Asia Pacific

Track 1: Current Regulations and Quality Standards
Track 1-1 FDA regulations and CFR
Track 1-2 EU-GMP guidelines
Track 1-3 WHO-GMP guidelines
Track 1-4 Role of Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S)
Track 1-5 Asia Pacific: GMP Regulations


Track 2: Current GMP Guidelines for Pharmaceuticals
Track 2-1 GMP for Active Pharmaceutical Ingredients (API)
Track 2-2 Ophthalmic solutions
Track 2-3 Parenterals
Track 2-4 Topical solutions
Track 2-5 Recombinant DNA products and cellular therapeutic agents
Track 2-6 Licensing in pharmaceutical production
Track 2-7 Packaging materials
Track 2-8 GMP's for Pharmaceutical Excipients


Track 3: GLP, GCP, and cGMP
Track 3-1 Food processing technologies
Track 3-2 Finished products management
Track 3-3 Recall system under GMP
Track 3-4 Marketing authorizations
Track 3-5 Standard operating procedures (SOP)
Track 3-6 Biological waste management



Track 4: Clinical Trial Regulations
Track 4-1 Regulatory approval and role of FDA in GLP
Track 4-2 GLP's in pre-clinical studies
Track 4-3 Global current techniques to improve clinical trial practices
Track 4-4 Quality and risk management
Track 4-5 Challenges and solutions of clinical trials
Track 4-6 Pharmaceutical clinical trial legislation



Track 5: Good Clinical Practice
Track 5-1 Role of ICH in designing GCP principles
Track 5-2 Institutional review boards and the informed consent process
Track 5-3 Responsibilities of sponsors and investigators
Track 5-4 Ethical aspects in clinical trials
Track 5-5 Post-approval regulatory requirements



Track 6: Investigational Medicinal Products
Track 6-1 Regulatory requirements for IMPs
Track 6-2 Inspection at investigational sites
Track 6-3 Requirements for labelling and packaging
Track 6-4 Non IMP requirements



Track 7: Legal Requirements for Medical Devices
Track 7-1 Regulatory requirements
Track 7-2 Design controls
Track 7-3 Validation/qualification
Track 7-4 Regulatory audits
Track 7-5 CAPA and risk management



Track 8: Computational Strategies in GMP/GCP
Track 8-1 Implementation of computerised systems
Track 8-2 Suppliers, software developers, and quality management
Track 8-3 QMS and software standards attributes
Track 8-4 Computational validation and audits
Track 8-5 GAMP validation approach



Track 9: GMP Meets GCP
Track 9-1 Interface between GMP and GCP
Track 9-2 GMP and GCP inspections
Track 9-3 Role of qualified person in GMP and GCP
Track 9-4 Quality indicators in GMP/GCP