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:8/1/2019)... ... August 01, 2019 , ... The GENSPEED platform is ... care. It is fully developed with over 100 units deployed in the field ... fields of use, our collaboration with axiVEND will give us a foothold in the ...
(Date:8/1/2019)... ... 2019 , ... Advancements with Ted Danson to focus on ... , Factor Bioscience Inc. (Factor) is pioneering nucleic-acid and cell-based technologies to advance ... of Advancements will explore how Factor Bioscience is building the future of regenerative ...
(Date:7/24/2019)... ... July 24, 2019 , ... NDA Partners Chairman Carl ... with more than 20 years of experience working in scientific research and FDA-regulated ... as an Expert Consultant. , Dr. Hartzfeld has experience in all aspects of ...
Breaking Biology News(10 mins):
(Date:8/6/2019)... ... August 05, 2019 , ... Advanced Clinical, a ... a distinguished leader by PharmaVOICE magazine, earning him a prestigious spot on the ... July/August special issue. , As the executive vice president of business development and ...
(Date:7/26/2019)... ... July 25, 2019 , ... LeadingBiotech ... and dialogue, today announces its Boston BD conference to be held ... Biotech Week Boston , the event provides an opportunity for attendees to ...
(Date:7/17/2019)... (PRWEB) , ... July 15, 2019 , ... CRISPR is ... that a certain trait can be removed, replaced, or edited, but Yiping Qi, assistant ... far beyond these traditional applications in his latest publication in Nature Plants. In this ...
(Date:7/9/2019)... ... July 08, 2019 , ... Today, at the ... National Corn Growers Association (NCGA) announced the winners of the Consider Corn ... product or process using field corn to produce biobased materials. , “Corn is a ...
Breaking Biology Technology: