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:11/25/2015)... ... November 25, 2015 , ... A long-standing ... Aerospace Professionals (OPBAP) has been formalized with the signing of a Memorandum of ... with OPBAP leaders Capt. Karl Minter and Capt. Albert Glenn Tuesday, November 24, ...
(Date:11/24/2015)... ... ... The United States Golf Association (USGA) today announced Dr. Bruce Clarke, of ... since 1961, the USGA Green Section Award recognizes an individual’s distinguished service to the ... of Iselin, N.J., is an extension specialist of turfgrass pathology in the department of ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... year and one of the premier annual events for pharmaceutical manufacturing: 2015 Annual ... November 2015, where ISPE hosted the largest number of attendees in more than ...
(Date:11/24/2015)... ... November 24, 2015 , ... The Academy of Model Aeronautics ... (SIG), MultiGP, also known as Multirotor Grand Prix, to represent the First–Person View (FPV) ... Many AMA members have embraced this type of racing and several new model aviation ...
Breaking Biology Technology:
(Date:11/19/2015)... MOUNTAIN VIEW, Calif. , Nov. 19, 2015 /PRNewswire/ ... authentication market, Frost & Sullivan recognizes BIO-key with the ... Strategy Leadership. Each year, Frost & Sullivan presents this ... comprehensive product line catering to the needs of the ... which the product line meets and expands on customer ...
(Date:11/18/2015)... 18, 2015  As new scientific discoveries deepen our ... other healthcare providers face challenges in better using that ... In addition, as more children continue to survive pediatric ... and old age. John M. Maris, M.D ... of Philadelphia (CHOP) . --> John ...
(Date:11/17/2015)... November 17, 2015 Paris ... --> Paris from 17 th ... the biometrics innovation leader, has invented the first combined scanner ... the same scanning surface. Until now two different scanners were ... scanner can capture both on the same surface. This ...
Breaking Biology News(10 mins):