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:
  - 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

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
  - 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)

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

Part 1
Friday	03.11.2023 von 08:30 - 18:30 Uhr	Universitätsclub Bonn e.V.
Saturday	04.11.2023 von 08:00 - 16:00 Uhr	Universitätsclub Bonn e.V.

Part 2
Friday	17.11.2023 von 08:30 - 18:30 Uhr	Online
Saturday	18.11.2023 von 08:00 - 16:00 Uhr	Online

Part 3
Friday	01.12.2023 von 08:30 - 18:30 Uhr	Online
Saturday	02.12.2023 von 08:00 - 16:00 Uhr	Online
Submission of study paper	Thursday, 03.11.2022