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:1/24/2017)... /PRNewswire/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), ... active lead drug candidate, PBI-4050, has been issued a ... and Healthcare Products Regulatory Agency ("MHRA") for the treatment ... designation is an early indication that a medicinal product ... Medicines Scheme ("EAMS"), intended for the treatment, diagnosis or ...
(Date:1/24/2017)... ... January 23, 2017 , ... Edward ... first-ever recipient of the National Academy of Sciences Prize in Food and Agriculture ... nutrition. , The annual National Academy of Sciences (NAS) Prize in Food and ...
(Date:1/24/2017)... , Jan. 23, 2017  Recognizing the ... on scientific discovery and solutions, the University of ... Frost Institutes for Science and Engineering to achieve ... mathematics (STEM) to help solve some of the ... Miami President Julio Frenk unveiled the ...
(Date:1/24/2017)... 2017   Instrument Business Outlook ( ... MN ) the 2016 Company of the ... newsletter tracking developments in the analytical and life ... consistently achieved outstanding technical, operational and financial results ... of IBO. "In 2016, Bio-Techne capitalized on opportunities ...
Breaking Biology Technology:
(Date:1/4/2017)... -- For the thousands of attendees at this year,s International Consumer Electronics Show ... biometric measurement devices and services, will be featuring its new line of ... Medical,s special CES Exhibit Suite , the new upper arm and ... WellnessConnected product platform.  Continue ... ...
(Date:12/20/2016)... 2016 The rising popularity of mobility ... is stoking significant interest in keyless access systems. ... low energy (BLE), biometrics and near-field communication (NFC) ... of wireless technologies in the automotive industry. This ... access systems opens the market to specialist companies ...
(Date:12/16/2016)... , Dec. 16, 2016 The global wearable medical ... 12.14 billion by 2021 from USD 5.31 billion in 2016, at ... ... mainly driven by technological advancements in medical devices, launch of a ... preference for wireless connectivity among healthcare providers, and increasing focus on ...
Breaking Biology News(10 mins):