Navigation Links
Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars, New Webinar Hosted by Xtalks
Date:3/29/2019

In the development of biosimilars, the broad definition of the similarity concept in regulatory guidelines does not directly prescribe a path for this task. Despite this uncertainty, several manufacturers have been successful and numerous follow-on biologics are approved in the US and EU as of today. In the first part of this webinar, learn how analytical similarity is achieved in biosimilars based on recently approved products in the US. This overview is complemented with analytical examples from functional assays and glycan structure analysis to illustrate the significance of data interpretation in support of the regulatory dossier.

In the second part of this webinar, attendees will learn about the analytical development and regulatory strategies pertaining to new biological entities. The examples focus once more on the importance of understanding the data and analyzing similarity by interpreting differences within the molecular context utilizing prior knowledge.

In the third part of this webinar, common specifications for biotherapeutic products will be presented. This discussion will include common push back and observations from North American and European regulators. Further case studies will be presented to illustrate strategies used to successfully avoid common regulatory traps.

Join Thomas Linnemann, PhD, Head of Regulatory CMC Customer Solutions at Solvias in a live session on Wednesday, April 17, 2019 at 1pm EDT to explore these topics and find out why data interpretation is essential to product development.

For more information or to register for this event, visit Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) 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://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Read the full story at https://www.prweb.com/releases/regulatory_strategies_for_the_analytical_development_of_new_biological_entities_and_biosimilars_new_webinar_hosted_by_xtalks/prweb16202471.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related biology news :

1. GW researcher discovers new regulatory autism gene
2. New tool developed for profiling critical regulatory structures of RNA molecules
3. Survey reveals regulatory agencies viewed as unprepared for nanotechnology
4. Penn biologists establish new method for studying RNAs regulatory footprint
5. A study using Drosophila flies reveals new regulatory mechanisms of cell migration
6. Counting fish teeth reveals regulatory DNA changes behind rapid evolution, adaptation
7. Combining strategies speeds the work of enzymes
8. New report offers science-based strategies for management of western free-ranging horses and burros
9. Recent progress in gene-sensing strategies for rapid detection of foodborne pathogens
10. Study recommends strategies for improved management of fresh market spinach
11. Climate change, people and ecosystems:Assessing strategies for adaptation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/12/2019)... DIEGO (PRWEB) , ... April 11, 2019 , ... Neal ... than 35 years of global experience. He is executive director of the consumer advocacy ... high school students. Neal was a member of the Federal Communications Commission’s Cybersecurity Roundtable ...
(Date:4/9/2019)... ... 09, 2019 , ... The McLeod Center for Cancer Treatment and Research ... and voluntary audit conducted by an independent, third-party panel of experts in radiation oncology, ... the United States, McLeod is the only such cancer center in South Carolina. The ...
(Date:4/4/2019)... ... 2019 , ... The live session taking place ... connectivity between product risk management (ISO 14971) and the clinical risk management process ... With increasing global regulation and reimbursement challenges faced by medical device companies, it ...
Breaking Biology News(10 mins):
(Date:4/4/2019)... ... , ... Biomeme, Inc. , a leading manufacturer of ... for performing PCR, RT-PCR, qPCR, and Isothermal tests called Franklin ™. The ... English chemist and X-ray crystallographer who made significant contributions to the understanding of ...
(Date:3/29/2019)... ... March 28, 2019 , ... Specific Diagnostics ... has proceeded with a second stage of funding for Specific’s Reveal™ rapid antibiotic ... on top of the $1.7 million already awarded by CARB-X. The additional $1.7M ...
(Date:3/27/2019)... ... ... In honor of National Nutrition Month, Lajollacooks4u has collaborated with the San ... nutrition. This month, Chef Jodi Abel appeared on two segments on KUSI’s Good ... segment addressed the nutritional value of USDA’s MyPlate, a nutrition guide that simplifies the ...
(Date:3/23/2019)... ... March 22, 2019 , ... uBiome has awarded microbiome research ... researchers at Nnamdi Azikiwe University in Anambra State, Nigeria led by Dr. Kingsley ... Department of Medical Laboratory Sciences and Deputy Provost, College of Health Sciences. The ...
Breaking Biology Technology: