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:9/19/2017)... ZirMed Inc ., a recognized leader in cloud-based revenue cycle ... ranked #1 by its users for the seventh consecutive year ... ZirMed was recognized as the top-ranked end-to-end revenue cycle management ... 200 beds and holds one of the longest #1 ranking ... ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has ... the Atlanta Football Host Committee (AFHC) for the 2018 College ... Jan. 8, 2018, at Mercedes-Benz Stadium in Atlanta, ... of the AFHC "I,m In" campaign, participating in many activities ... ...
(Date:9/12/2017)... , Sept. 12, 2017  ValGenesis Inc., the ... (VLMS), is pleased to announce the appointment of ... of its Board of Directors and Chairman of ... enables life science companies to manage their entire ... of paper in this process. Furthermore, ValGenesis VLMS ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... giving viewers the lowdown on sciatica in a new episode of "Success Files," ... on current events and innovation and investigates each subject in-depth with passion and ...
(Date:10/12/2017)... ... 12, 2017 , ... First Healthcare Compliance (FHC), an industry ... a range of technology and learning solutions at the 68th Annual American Healthcare ... be held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... the introduction of an innovative new design of the shoulder pad. The shoulder ... maximum comfort while controlling your pain while using cold therapy. By utilizing ice and ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the Los ... article to the newly revamped Cosmetic Town journal section, featuring articles ... procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi says ...
(Date:10/12/2017)... Mich. (PRWEB) , ... October 12, 2017 , ... ... has been named one of Michigan’s 2017 Best and Brightest in Wellness® by ... Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to ...
Breaking Medicine News(10 mins):