Navigation Links
Xtalks Life Sciences Webinar Examines Safety Assessment of Biosimilars
Date:1/15/2014

Toronto, Canada (PRWEB) January 15, 2014

This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars.

Regulatory frameworks are evolving many countries to guide a path for biosimilar drug development, however the complex nature of biopharmaceuticals makes the demonstration of biosimilarity with regards to quality, safety and efficacy extremely challenging. Based on the specific aspects of biosimilar drug development and registration, development strategies differ significantly from the development of an innovator product that has to establish both the efficacy and safety independently from other products.

The webinar will review:

  •     EMA guidelines on Biosimilar mAbs
  •     EMA vs. FDA regulation including a discussion of WHO guidance
  •     Current global regulatory environment
  •     Case studies and ongoing challenges

A live Q&A with the audience will follow the main presentation.

For more information about this event or to register, visit: http://xtalks.com/xto706-biosimilars-safety-assessment.ashx.

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit http://www.xtalks.com.

For information about hosting a webinar, visit http://www.xtalks.com/sponsorship.ashx.

Contact:
Zayeeta Dasgupta, M.Sc in Life Science and Business Management
1- (416) 977-6555 ext. 260

Read the full story at http://www.prweb.com/releases/2014/01/prweb11484074.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services
2. Pros and Cons of Adaptive Designs: A Leisurely Conversation Between a Clinician and Two Statisticians, New Webinar Hosted by Xtalks
3. A Review of Cardiovascular Pressure Sensing and Relevant Performance Specifications to Ensure Data Integrity, a New and Upcoming Webinar Hosted by Xtalks
4. Catching up with the Genomic Era in Oncology: Key Considerations for Incorporating Genomics into Oncology Drug Development, a New and Upcoming Webinar Hosted by Xtalks
5. Patient-Centric Technology for Better Trial Outcomes, a New and Upcoming Clinical Trial Webinar Hosted by Xtalks
6. UV-C Treatment—a New Procedure for Viral Inactivation, New and Upcoming Webinar Hosted by Xtalks
7. Lessons Learned in Launching a Prognostic Test Based On Tissue Image Analysis, New and Upcoming Webinar Hosted by Xtalks
8. Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications, a New and Upcoming Drug Safety Webinar Hosted by Xtalks
9. Respiratory Update: Interpreting Minimal Clinically Important Differences in COPD and Demonstrating Product Value with PROs, a New Life Science webinar Hosted by Xtalks
10. Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends, A New Drug Safety Webinar from Xtalks
11. Data-driven Site Negotiations: Fast Track to Fair Market Value (FMV), a New Clinical Trials Webinar from Xtalks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 2016 , ... Researchers at the Universita Politecnica delle Marche in Ancona combed ... pleural mesothelioma. Their findings are the subject of a new article on the Surviving ... signposts in the blood, lung fluid or tissue of mesothelioma patients that can help ...
(Date:6/23/2016)... CAMBRIDGE, Mass. , June 23, 2016 /PRNewswire/ ... the development of novel compounds designed to target ... compound, napabucasin, has been granted Orphan Drug Designation ... in the treatment of gastric cancer, including gastroesophageal ... cancer stemness inhibitor designed to inhibit cancer stemness ...
(Date:6/23/2016)... HOUSTON , June 23, 2016 ... agreement with the Cy-Fair Sports Association to serve ... of the agreement, Houston Methodist Willowbrook will provide ... education and connectivity with association coaches, volunteers, athletes ... partner with the Cy-Fair Sports Association and to ...
(Date:6/23/2016)...  The Biodesign Challenge (BDC), a university competition that ... living systems and biotechnology, announced its winning teams at ... New York City . The teams, ... at MoMA,s Celeste Bartos Theater during the daylong summit. ... curator of architecture and design, and Suzanne Lee ...
Breaking Biology Technology:
(Date:4/26/2016)... 27, 2016 Research and ... Biometrics Market 2016-2020"  report to their offering.  , ... The analysts forecast the global multimodal biometrics ... during the period 2016-2020.  Multimodal biometrics ... such as the healthcare, BFSI, transportation, automotive, and ...
(Date:4/14/2016)... 14, 2016 BioCatch ™, ... today announced the appointment of Eyal Goldwerger ... Goldwerger,s leadership appointment comes at a time ... the deployment of its platform at several of the ... which discerns unique cognitive and physiological factors, is a ...
(Date:3/29/2016)... 29, 2016 LegacyXChange, Inc. (OTC: ... and SelectaDNA/CSI Protect are pleased to announce our successful ... a variety of writing instruments, ensuring athletes signatures against ... collectibles from athletes on LegacyXChange will be assured of ... DNA. Bill Bollander , CEO states, ...
Breaking Biology News(10 mins):