1 |
|
European Union |
|
|
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
|
|
|
b) Centralised Procedure • Eligibility • Pre-submission Activities • Marketing Authorisation Application Submission • Assessment Process • Post-Opinion Period / Decision Making Process • Post-Authorisation Activities
|
|
|
c) Key Milestones in the CP • The EMA Product Team • Frequency of Interactions • Clarification Meeting, Oral Explanation
|
|
|
d) Marketing Authorisation Procedures • Legal Basis & procedures • National Procedure • MRP and Decentralised Procedure
|
|
|
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
|
|
|
f) Addressing Innovation and Unmet Needs • Conditional Approval • Accelerated Approval • Exceptional Circumstance
|
|
|
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
|
|
|
i) Introduction to Similar Biological Medicinal Products |
|
|
k) Regulatory Intelligence: Highlights and Developments • PRIME scheme • Public hearing • Brexit Preparedness • Industry Stakeholder Platform
|
|
|
|
2 |
|
EU (Continuation), Switzerland, International Markets |
|
|
a) Paediatrics • General Considerations • Paediatric Committee • Paediatric Investigation Plan
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
g) China • China Health Authority • Regulations • Clinical Trials • Marketing Authorization • Maintenance
|
|
|
h) General Considerations for International Drug Registration • WHO Initiatives: o Essential Medicines o Prequalification o 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
|
|
|
k) EE, Middle East, Africa • Russia, • Turkey, • South Africa
|
|
|
l) Asia-Pacific • Korea • Taiwan • India • ASEAN
|
|
|
|
3 |
|
USA |
|
|
a) Introduction • US Pharma Market • History of Key Regulations • Organisation of HHS
|
|
|
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 o Pre-NDA Submission o NDA Content and Format o 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)
|
|
|
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
|
|
|
g) Post-Approval Activities • Reporting Requirements to FDA • Changes to Approved Product
|
|
|
h) Comparison US vs. EU |