Masterstudiengang „Drug Regulatory Affairs"

Studienmodule

Modul 03 (WS 2019/ SS 2020)

Zulassung international

Präsenzzeit Studienarbeiten Prüfungsform Leistungspunkte
ca. 45 Stunden ca. 30 Stunden Studienarbeit und Klausur 7

Modulleiter/in

  • Dr. Ekkehard Baader

Themen

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 

Studienplan

Teil 1:

   
Freitag   08. November 2019 von 8.30 - 18.30 Uhr
Samstag   09. November 2019 von 8.00 - 16.00 Uhr
Ort:    BfArM, Kurt-Georg-Kiesinger-Allee 3, Bonn

Teil 2:

   
Freitag    22. November 2019 von 8.30 - 17.30 Uhr
22. November 2019 Cortellis Schulung von 17.45 - 19.45 Uhr
Samstag     23. November 2019 von 8.00 - 16.00 Uhr
Ort:    Uni-Club

Teil 3:

   
Freitag   06. Dezember 2019 von 8.30 - 18.30 Uhr
Samstag   07. Dezember 2019 von 8.00 - 16.00 Uhr
Ort:    BfArM, Kurt-Georg-Kiesinger Allee 3, Bonn
     
    Abgabe Studienarbeit: 06.01.2020

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