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Global CTD Dossier: Regulatory aspects and focus on quality documentation including concepts of Quality by Design

Dec 1 2013 8:00AM - Dec 3 2013 5:00PM | Radisson BLU Hotel, Dubai Deira Creek P.O. Box 476 Dubai United Arab Emirates

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Overview 

High quality of a registration dossier facilitates the registration procedure - Essential for Generics! This course provides a comprehensive description on the Common Technical Dossier structure – completely updated to reflect the latest changes in pharmaceutical regulatory affairs. The course provides an excellent opportunity to gain an overview of regulatory aspects and includes discussion of the relevant legislation. The requirements for the Quality documentation (Module 2.3 & 3) will be presented in detail, taking into account the recent ICH-Q guidelines. The course is for new developments, but is also very much attractive for Generics. In addition, this training course addresses Quality by Design aspects and issues.

Participants will be involved in case studies, group works and have to present the outcome.

Key Topics

  • CTD, eCTD
  • Regional requirements of EU Module 1
  • Regulatory environment:
    • New applications
    • Past approval changes
  • Risk based approach
  • Module 3
    • Pharmaceutical Development and Quality Risk Management
    • Quality of Active Substance including Purity Issues (ASMF, CEP)
    • Impurity Testing
    • Stability Testing
    • Setting of Specifications
    • Design Space
    • Control Strategy

Who Should Attend 

  • Governmental Institutions
  • Pharmaceutical Industry
    • Development Managers and Experts
    • QA and New Manufacturing Managers

Level: Beginner to intermediate

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Identify the recent requirements for developing drug substance and drug products and setting up a registration dossier - especially for generics
  • Define the requirements for developing a product and discuss how to prepare the regional EU Module 1 and the Quality documentation
  • Discuss the legal background of the dossier requirements and identify the relevant guidelines
  • Demonstrate optimal presentation of information and justifications

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

Radisson Blu Hotel Dubai Deira Creek
P.O. Box: 476
Dubai, United Arab Emirates
Tel: +971 4 222 7171
Fax: +971 4 223 7615
info.deiracreek.dubai@radissonBlu.com

at the special rate of:
EUR 130.00 per room inclusive of breakfast, exclusive of 10% municipality tax and 10% service charge.

To make your reservation please use this booking form:

Hotel Booking Form

Important: The room rate is available until 24 October 2013 or until the group block is sold-out, whichever comes first.


Contact Information 

DIA Europe

KUECHENGASSE 16, POSTFACH

4002 BASEL

SWITZERLAND

 

TEL.: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

Faculty 

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Registration Fees 

Member

Charitable Nonprofit/Academia Member
€893.00
Member Government
€893.00
Member Standard
€1785.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€1008.00
NonMember Government
€1008.00
NonMember Standard
€1900.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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