Using Early Scientific Advice in DruDevelopment: Opportunities and Challenges, Upcoming Webinar Hosted by Xtalks

Share Article

In this free webinar, the featured speakers will provide insights on the pros and cons of seeking scientific advice from regulatory and HTA bodies separately and/or in parallel and the impacts of Brexit on the NICE SA process. Attendees will learn how to best time SA requests and build a comprehensive and effective dossier/briefing book.

Xtalks Life Science Webinars

Manufacturers must now also consider the impact of Brexit on existing SA processes.

In Europe, “scientific advice” (SA) refers to an early dialogue between a manufacturer, health technology assessment (HTA) bodies and/or regulators on initial evidence generation for relative effectiveness and cost effectiveness assessments. The SA and parallel scientific advice (PSA) processes are valuable in helping companies to develop evidence that demonstrates the value of their product, to gain detailed feedback on their evidence generation plans, to integrate cost-effectiveness considerations into health technology assessments (HTA) and to better understand the concerns and perspectives of HTA and/or regulatory decision makers.

Manufacturers must now also consider the impact of Brexit on existing SA processes. For example, while the UK National Institute for Health and Care Excellence (NICE) is a leader due to the potential applicability of its advice to over 20 countries, it will no longer be able to provide parallel advice with the European Medicines Agency (EMA) through the European Network for Heath Technology Assessment (EUnetHTA) and will have to develop concurrent advice.

Join Celine Taveau, Principal, Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc and Emmanuel Lacharme, Senior Consultant, Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc in a live webinar on Thursday, September 10, 2020 at 11am EDT (4pm BST/UK).

For more information or to register for this event, visit Using Early Scientific Advice in Drug Development: Opportunities and Challenges.

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/

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Sydney Perelmutter
Xtalks
+1 (416) 977-6555 x 352
Email >
Visit website