1 European Union
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| a) Legal Basis and Key Players |
- The Role of the EU Commission, Council and European Parliament
- European Regulations, Directives, Decisions, Guidelines
- European Medicines Agency, Scientific Committees
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| b) Centralised Procedure |
- Eligibility
- Pre-submission Activities
- Marketing Authorisation Application Submission
- Assessment Process
- Post-Opinion Period / Decision Making Process
- Post-Authorisation Activities
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| c) Key Milestones in the CP |
- The EMA Product Team
- Frequency of Interactions
- Clarification Meeting, Oral Explanation
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| d) Marketing Authorisation Procedures |
- Legal Basis & procedures
- National Procedure
- MRP and Decentralised Procedure
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| e) Generics – Peculiarities and Special Features |
- Generic Product
- Reference Product
- Global Marketing Authorisation
- Data Exclusivity / Market Exclusivity
- Patents
- Hybrid Applications
- Submission Strategy
- DCP – Theory and Practice
- Flexibility of the DCP
- Generics in CP
- International Generic Drug Regulators Program
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| f) Addressing Innovation and Unmet Needs |
- Conditional Approval
- Accelerated Approval
- Exceptional Circumstance
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| g) Community Referrals |
| h) Scientific Advice in Europe |
- Reasons for Obtaining Scientific Advice
- Procedures for Requesting Scientific Advice
- Key Aspects of a Scientific Advice Strategy
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| i) Introduction to Similar Biological Medicinal Products |
| k) Regulatory Intelligence: Highlights and Developments |
- PRIME scheme
- Public hearing
- Brexit Preparedness
- Industry Stakeholder Platform
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2 EU (Continuation), Switzerland, International Markets
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| a) Paediatrics |
- General Considerations
- Paediatric Committee
- Paediatric Investigation Plan
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| b) Orphan Medicinal Products |
- Historical Background of International Legislations
- Legal Basis of EU Orphan legislation
- Some Clarifications and Definitions
- Criteria and procedures for Orphan Designation
- Market Exclusivity and Similarity
- Overview of Existing Orphans
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| c) Switzerland |
| d) ICH |
| e) Canada/Australia |
Canada
- Health Authority
- Structure of Health Canada
- Process of New Drug Submission (NDS)
- NDS Case Example and Review Times
- Maintenance
- CTA Clinical Development
- Submission Types and Timelines
Australia
- Health Authority - Structure of TGA
- Process of New Drug Application (NDA)
- Maintenance
- CTA Clinical Development
- Others RA Environment
- Trans Tasman Agency
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| f) Japan |
- Japanese Regulation of the Drug Market
- The Japanese Health Authority
- ICH and its Role in Japan
- Health Authority Meetings and Clinical Trial Applications
- The Review Process
- Reexamination / Reevaluation
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| g) China |
- China Health Authority
- Regulations
- Clinical Trials
- Marketing Authorization
- Maintenance
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| h) General Considerations for International Drug Registration |
- WHO Initiatives:
- Essential Medicines
- Prequalification
- Certification Scheme
- Reference Country
- Documentation Requirements
- Extrapolation of Foreign Clinical Data
- Stability Data
|
| i) Latin America |
- PANDRH (Pan American Network for Drug Regulatory Harmonization)
- Argentina
- Brazil
- Mexico
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| k) EE, Middle East, Africa |
- Russia,
- Turkey,
- South Africa
|
| l) Asia-Pacific |
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3 USA
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| a) Introduction |
- US Pharma Market
- History of Key Regulations
- Organisation of HHS
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| b) IND Process |
- Legal Framework
- Principles, Dossier
- Review, Approval and Maintenance Process
- Clinical Hold
|
| c) NDA Process |
- US Code of Federal Regulations (CFR)
- PDUFA
- Good review Management Principles and practices
- Pre-NDA Submission
- NDA Content and Format
- NDA Review Process
- Future Development
|
| d) Pediatrics |
- Pediatric Legislation Goals
- Pediatric Research Equity Act (PREA) - Requirements, Waiver, Deferrals
- Best Pharmaceuticals for Children’s Act (BPCA) – Written Request, NIH Programs
- Pediatric Review Committee (PeRC)
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| e) Market Exclusivity / ANDA |
- Submission Date – Exclusivities and Patents
- Selection of Application Type – ANDA or “Hybrid”
- Points to Consider in Development / before Filing
- Drug Approval Process – Patent Certification & Review Process
|
| f) How to Cooperate with FDA |
- Scientific Advice
- Fast Track
- Early Access
- Accelerated Approval
- Surrogate Endpoints
- Rolling NDA
- Orphan Drugs
- Special Protocol Assessment
- Advisory Committees
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| g) Post-Approval Activities |
- Reporting Requirements to FDA
- Changes to Approved Product
|
| h) Comparison US vs. EU |
