Masterstudiengang „Drug Regulatory Affairs"

Studienmodule

Modul 03 (WS 2018 / SS 2019)

Zulassung international

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

Modulleiter/in

  • Dr. Ekkehard Baader, Budapest

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:
    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

Studienplan

Teil 1:    
Freitag   09. November 2018 von 8.30 - 18.30 Uhr
Samstag   10. November 2018 von 8.00 - 16.00 Uhr
Ort:    BfArM, Kurt-Georg-Kiesinger-Allee 3, Bonn
Teil 2:    
Freitag    23. November 2018 von 8.30 - 18.00 Uhr
Samstag     24. November 2018 von 8.00 - 16.00 Uhr
Ort:    Uni-Club
Teil 3:    
Freitag   07. Dezember 2018 von 8.30 - 18.30 Uhr
Samstag   08. Dezember 2018 von 8.00 - 16.00 Uhr
Ort:    BfArM, Kurt-Georg-Kiesinger Allee 3, Bonn
     
    Abgabe Studienarbeit: 07.01.2019

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