Navigation Links
Xtalks Life Sciences Webinar Examines Safety Assessment of Biosimilars

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:

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

For information about hosting a webinar, visit

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

Read the full story at

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:
(Date:6/23/2016)... /PRNewswire/ - FACIT has announced the creation of ... company, Propellon Therapeutics Inc. ("Propellon" or "the Company"), ... portfolio of first-in-class WDR5 inhibitors for the treatment ... represent an exciting class of therapies, possessing the ... cancer patients. Substantial advances have been achieved with ...
(Date:6/23/2016)... 2016 Houston Methodist Willowbrook Hospital has ... Association to serve as their official health care ... Willowbrook will provide sponsorship support, athletic training services, ... coaches, volunteers, athletes and families. "We ... Association and to bring Houston Methodist quality services ...
(Date:6/23/2016)... Prostate Cancer Foundation (PCF) is pleased to announce 24 new Young ... cancer. Members of the Class of 2016 were selected from a pool of ... More About the Class of 2016 PCF Young Investigators ... ... ...
(Date:6/23/2016)... , June 23, 2016   EpiBiome , ... secured $1 million in debt financing from Silicon Valley ... up automation and to advance its drug development efforts, ... new facility. "SVB has been an incredible ... the services a traditional bank would provide," said Dr. ...
Breaking Biology Technology:
(Date:6/20/2016)... , June 20, 2016 Securus Technologies, ... technology solutions for public safety, investigation, corrections and ... prisons involved, it has secured the final acceptance ... facilities for Managed Access Systems (MAS) installed. Furthermore, ... facilities to be installed by October, 2016. MAS ...
(Date:6/9/2016)... 9, 2016 Paris Police ... video security solution to ensure the safety of people and ... during the major tournament Teleste, an international technology ... services, announced today that its video security solution will be ... back up public safety across the country. The system roll-out ...
(Date:6/2/2016)... NEW YORK , June 2, 2016   The ... (Weather), is announcing Watson Ads, an industry-first capability in which ... advertising, by being able to ask questions via voice or ... Marketers have long ... with the consumer, that can be personal, relevant and valuable; ...
Breaking Biology News(10 mins):