• About Us
  • Home
Friday, June 9, 2023
No Result
View All Result
NEWSLETTER
WiredNewsEngine
  • Home
  • Press Release
  • Entertainment
  • Health
  • Legal
  • Business
  • Featured
  • Current
  • Home
  • Press Release
  • Entertainment
  • Health
  • Legal
  • Business
  • Featured
  • Current
No Result
View All Result
WiredNewsEngine
No Result
View All Result
Home Business

PDA European Workshop Offers Important Preview of EFPIA “Quality by Design” Documents

by WebMaster
September 16, 2009
in Business, Press Release
0
0
SHARES
0
VIEWS
Share on FacebookShare on Twitter

/EIN News/ Parenteral Drug Association (PDA) is offering delegates to its Quality by Design (QbD) workshop (Frankfurt, Germany 22/23 September 2009) an important opportunity to preview documents produced by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

The EFPIA “mock” documents (case studies) mimic a hypothetical application and reflect what would be done for a (bio-)chemical, pharmaceutical and analytical development conducted under a QbD approach for a biotech API and an injectable product. This work is being presented to PDA workshop delegates prior to presentation to European health policy-makers from the European Medicines Agency (EMEA) in London, UK on 28/29 September 2009. The documents’ authors will specifically seek input from workshop delegates on their presentations.

“The purpose of these case studies is to provide examples of how an S2 and P2 section might look for a parenteral product developed using an enhanced QbD development approach, as envisaged in ICH Q8R. They are not intended to be all-encompassing or to represent the only way that development of a parenteral product can proceed, or be presented”, said Brian Whithers, Abbott, Director CMC Regulatory and Co-Chair of EFPIA’s Product Development and CMC ad hoc group. “They are intended to stimulate thought and discussion of the possibilities that ICH Q8, 9 and 10 present for potential products.”

Robert Schnepf, Head of Drug Product Formulation and Process Development of New Biological Entities, Merck KGaA, said sharing best practices with EMEA and other countries supports claims of regulatory relief made in the ICH documents and helps the industry fine-tune their own practices. “Much too often the potential of applying QbD is not seen or underestimated. It might be considered too complicated, implying large workload, time and resources without immediate benefit. This PDA Workshop offers the opportunity to challenge all preconceptions and to learn from the example of the EFPIA groups how much of this is true.”

“I personally would like to invite delegates to this PDA Workshop. The coffee table format will help to convey the spirit and experiences of the discussions we had in our EFPIA groups”, said Graham Cook, Senior Director, Process Knowledge/Quality by Design. Wyeth Global Quality & Compliance. “Everything has been designed to ensure that participants will leave satisfied and enriched by the experience, with their issues addressed and discussed with a variety of subject matter experts.”

To book your place at the workshop please visit www.pda.org/QbD2009

WebMaster

WebMaster

Next Post

Sample 'Human Rights Today' for Free This Weekend

Popular News

  • Silencil Reviews – Does It Silence Tinnitus for Real?

    0 shares
    Share 0 Tweet 0
  • Clinitron Bed Management For Flap Patients Is The Standard Of Care

    0 shares
    Share 0 Tweet 0
  • How Substance Abuse Causes Risky Behavior

    0 shares
    Share 0 Tweet 0
  • Organic Green CBD Review: Is OrganicGreen Hemp CBD Oil Safe?

    0 shares
    Share 0 Tweet 0
  • Ceremony CBD Oil Reviews: Trustworthy Hemp CBD Liquid Drops?

    0 shares
    Share 0 Tweet 0

Rehabs Near Me Launches New Rehab Services in the US

February 25, 2021

Ginger-Powered Recoup Beverage: A Founder’s Unlikely Story of Survival and Success

February 13, 2021

What is Unix: The Base of All Operating Systems?

February 2, 2021

Categories

  • Banking
  • Bollywood
  • Brand Partner Content
  • Business
  • Cancer
  • Current
  • Entertainment
  • Featured
  • Finance
  • Health
  • Hollywood
  • Legal
  • Press Release
  • Technology
  • World News
  • Home
  • Press Release
  • Entertainment
  • Health
  • Legal
  • Business
  • Featured
  • Current

No Result
View All Result
  • About Us
  • Home