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A Regulatory Perspective of Biosimilars in Emerging Markets

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Overview 

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


With a number of innovator biologicals going off patent, biosimilars present a promising opportunity and a high market potential. However, unlike small molecules, which have known chemical structures, structure activity relationships and well-defined chemical synthesis processes, biosimilars are complex proteins requiring multistep multifaceted manufacturing processes. Hence the development of biosimilars presents unique and complex challenges which need to be strategically planned.

As pharmaceutical business interests spread to Latin America and the Asia Pacific regions, understanding aspects of the regulatory environment in those regions became a critical success factor. This webinar will provide high-level insight into the regulatory framework for biosimilar product development in key Latin America and Asia Pacific markets. There will be a discussion of a practical case study involving different marketed biosimilar formulations of a known innovator biological product and the practical implications thereof.


Archived Webinar Available through August 31, 2014


 

Who Should Attend 

This webinar is designed for professionals involved in:

  • Pharmaceutical Executives
  • Biomedical Product Developers
  • Regulatory Affairs Professionals
  • Clinical and Nonclinical Researchers
  • Biostatisticians and Data Managers

Learning Objectives 

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

  • Identify the key regulatory instruments related to the development and approval of biosimilar products in key markets of the Latin America (Brazil, Argentina and Mexico) and Asia Pacific (India, China, Korea) regions.
  • Recognize the similarities and differences in the regulatory requirements in these markets

Contact Information 

Archived Webinar Details
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, Aug 29, 2013

  • 7:00AM - 11:59PM

    A Regulatory Perspective of Biosimilars in Emerging Markets

    Speaker(s):

    • Biosimilars: Regulatory Environment in the Asia Pacific Region
      Sonica Sachdeva Batra
      Director Clinical Development, Biologics
      Dr. Reddy’S Laboratories Ltd., India
    • Latin American Biosimilar Regulations
      Oliver Cox, MSc
      Consultant
      PAREXEL International, United Kingdom

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$995.00

Member

Member Government Individual
$125.00
Member Academia Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government
$125.00
NonMember Academia Individual
$175.00
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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