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Certificates of Pharmaceutical Products for Regulatory Submissions

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Overview 

Continuing Education credit or Certificate Program units are not available for Archived Webinars.



This webinar focused on the requirements with regards to Certificates of Pharmaceutical Products (CPP) in regulatory submissions of medicines. The CPP is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. It is issued for a single product because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary. CPPs are needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. This webinar focused on CPPs, the purpose, history, WHO format, and legalization. Regional requirements and the impact of CPPs on submissions planning was discussed.


Archived Webinar available for purchase through June 1, 2014

Featured Topics 

  • Format and Content of Certificates of Pharmaceutical Products (CPP)
  • Legalization of CPP
  • Country of Origin
  • Planning submissions requiring CPP (first registrations/post-approval changes)
  • CPP versus Free Sales Certificates

Who Should Attend 

  • Regulatory Affairs
  • Technical/Scientific Writing
  • Quality Compliance/Quality Assurance
  • CMC Life Cycle Management
  • CMC Project Management

Learning Objectives 

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

  • Describe content of CPP, and legalization processes
  • Compare regional requirements with regards to CPP
  • Identify differences in CPP content

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET
CustomerService@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, May 23, 2013

  • 10:00AM - 11:59PM

    Certificates of Pharmaceutical Products for Regulatory Submissions

    Speaker(s):

    • Regional Requirements – Asia Pacific Region
      Rosanna Melchior, PharmD,MSc
      Senior Manager, Regulatory Intelligence
      Thomson Reuters, France
    • Regional Requirements for CPPs in the Middle East
      Angelika Michaelis-Gilles
      Senior Manager Global Regulatory Affairs Compound Development & Branding
      Gruenenthal GmbH, Germany
    • CPP Regional Requirements - Africa and Neighboring Countries
      Dellarika H. Schmitt, JD,LLM
      Sr. Manager Regulatory Policy, Emerging Markets Worldwide Regulatory Strategy
      Pfizer Inc, United States
    • Background on CPPs
      Marianne Vogt, MA
      Manager, Regulatory Operations (CSCC)
      Abbott GmbH & Co. KG, Germany
    • Introduction
      Yasmin de Faria Krim, PharmD,MSc
      Manager, Pharma Technical Regulatory Affairs
      Hoffmann-La Roche, France
    • Regional Requirements – CIS Region and Neighbouring Countries
      Rosanna Melchior, PharmD,MSc
      Senior Manager, Regulatory Intelligence
      Thomson Reuters, France
    • Regional Requirements for CPPs in Latin America
      Angelika Michaelis-Gilles
      Senior Manager Global Regulatory Affairs Compound Development & Branding
      Gruenenthal GmbH, Germany
    • The Content and Format of a CPP
      Marianne Vogt, MA
      Manager, Regulatory Operations (CSCC)
      Abbott GmbH & Co. KG, Germany
    • Impact of CPPs on Submission Planning
      Dellarika H. Schmitt, JD,LLM
      Sr. Manager Regulatory Policy, Emerging Markets Worldwide Regulatory Strategy
      Pfizer Inc, United States

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

NonMember Individual
$295.00
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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