Navigation Links
FDA to Address Industry Questions About Biosimilar Regulations at the Pharma's IQ Immunogenicity Event
Date:4/5/2011

LONDON, April 5, 2011 /PRNewswire/ -- This May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's to discuss FDA directives on immunogenicity introduced in 2008.  

Over the last two years, the regulations have been subject interpretation. Although the regulations were released in 2008, there has been some confusion within the industry as the regulations are subject to interpretation. The confusion arises around the tests have to be developed in order to get approval to develop a drug with a suitable level of immunogenicity.

Joao will provide the attendees with the reviewed FDA regulations and an analysis of the FDA implementation policy. He will also discuss how new FDA guidelines will influence the product development and how companies could make the most out of the pending regulations.

During his presentation, he will also assess the changing regulatory landscape and the practicalities of regulatory approval establishing relationships between immunogenicity assay development studies.

FDA session, Regulatory Update: An FDA Guidance for Industry; Understand Policy and Ensure Assay Development Within the Guidelines, will be part of the 2nd Annual Immunogenicity: Prediction, Detection and Effective Assay Development event, taking part 30 May - 01 June 2011 in Munich.

Other key sessions include:

  • Implementing the correct immunogenicity assay for successful drug development with an A-Z of everything you need to know with Dan Sikkema, GlaxoSmithKline
  • Ensuring global regulatory compliance with key insights from Joao Pedras-Vasconcelos, FDA and Meenu Wadhwa, NIBSC
  • Discovering novel in vitro and in vivo assay techniques to improve immunogenicity prediction methods with Bruce Green, Pfizer
  • Effectively applying theory to practice with insights into comparative immunogenicity studies with Birgit Reipert, Baxter
  • Keeping up-to-date with industry advances with clinical updates on the role of compliment in nanomedicines and biologicals with Janos Szebeni, Nanomedicine Research and Education Center, Bay Zoltan Foundation
  • Case Study: Developing Safe and Efficacious Drugs: How immunogenicity is impacting clinical affects of drug development and safety by Andrew Yates, Senior Group Leader, Drug Research & Development UCB
  • Case Study: Developing Standardised Assays to Allow Direct Comparisons of the Immunogenicity of Innovator Products and Biosimilars

If you want to find out more, please visit http://www.immunogenicity-event.com/PR, email enquire@iqpc.co.uk or call 44 (0) 207 368 9400.

CONTACT:

PHARMA IQ
Joanna Checinska

email: joanna.checinska@iqpc.co.uk
phone: 44(0)2073689300


'/>"/>
SOURCE Pharma IQ
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cantel Medical Corp.s Crosstex Subsidiary Addresses School MRSA Concerns With SaniTyze(TM) Brand Hand Sanitizer and Sanitex(R) Surface Disinfecting Line of Products
2. Olympic Gold Medalist Kristi Yamaguchi Joins American Lung Association of Michigan to Address Seriously Low Vaccination Rates; Urge Metro-Detroiters to Get Immunized This Season
3. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
4. MannKind Addresses Pfizers Announcement Regarding Exubera
5. Research Presented at ISHLT Shows Promise of Addressing Critical Organ Shortage and Better Organ Preservation
6. Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientific Session
7. Four Alzheimers Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation
8. Isogen Launches Major New Facility to Address Global Biopharma Demand
9. WBAL Radio Segment With Dr. Leigh Vinocur Addresses Hope for the Rosacea Sufferer
10. Investigational Genetic Test May Help Address Common Problems in Prostate Cancer Diagnosis
11. FDA Makes Interim Recommendations to Address Concern of Excess Radiation Exposure during CT Perfusion Imaging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released ... failing their residents by lacking a comprehensive, proven plan to eliminate ... a definitive ranking of how states are tackling the worst drug ... only four states – Kentucky , ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... report to their offering. ... a favourable commercial environment for MedImmune to enter. The US ... will serve to drive considerable growth for effective anti-influenza medications. ... cap sales considerably, but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their ... Eyeglasses . , Millions of individuals in the United States and Canada wear eyeglasses. ... way to both correct vision and make a fashion statement. Even celebrities use glasses ...
(Date:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
Breaking Medicine News(10 mins):