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:6/26/2016)... 26, 2016 Story Highlights: ... models within the health care industry is causing providers ... , Deloitte offers a suite of solutions for ... impacting efficient cost optimization: labor resource analysis, revenue cycle ... facilitate better outcomes and better economics ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):