In this free webinar, learn how a science-backed strategic approach always generates the best results and delivers successful regulatory submissions, ultimately speeding products to market in the most effective manner. Attendees will gain insights into using science to navigate the global regulatory maze. The featured speakers will discuss common submission points that people get wrong. Attendees will gain insights into using science to better define the benefit:risk profile of a medicine product. The speakers will discuss real-life examples of failed drug applications to the US Food and Drug Administration (FDA) or negative opinions given by the European Medicines Agency (EMA).
TORONTO, April 3, 2023 /PRNewswire-PRWeb/ -- The regulations governing drugs are built on the science employed in the development of these products. Worldwide, regulators find that submissions that correctly and easily describe the science behind a product are easier to read and agree with. In this webinar, ProPharma, the leading RCO, will explore how their mantra of "good science presented well" has ensured success when conducting clinical trials and preparing regulatory submissions.
It is important to work with clients to design studies that put client products in the best scientific light. For example: focusing on the optimal statistical process, the best animal model or the correct pharmacodynamic model. When working with regulators, science-based conversations have the best results. The featured speakers will talk about using the combined expertise of their clinical research and regulatory sciences groups to navigate any regulatory hurdles.
Register now to discover how a science-backed strategic approach always generates the best results and delivers successful regulatory submissions, ultimately speeding products to market in the most effective manner.
Join experts from ProPharma, Matthew Weinberg, President, Regulatory Sciences; and Sharon Charles, RN, MBA, VP, Clinical Operations, for the live webinar on Tuesday, April 18, 2023, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Navigating Regulatory Submissions with Science-Backed Strategies.
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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]
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Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
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