To initiate clinical trials during this pandemic, flexibility in process and advanced planning are vital and should be properly balanced with regulatory expectations, shortages of medicinal products approved in indications other than COVID-19 and competition for the trial participants.
TORONTO (PRWEB) May 28, 2020
Regulatory Agencies, Sponsors, CROs and sites all share the common goal of helping to get COVID-19 under control whether it’s by developing vaccines, diagnostics, or therapeutic agents for symptomatic treatments. To initiate clinical trials during this pandemic, flexibility in process and advanced planning are vital and should be properly balanced with regulatory expectations, shortages of medicinal products approved in indications other than COVID-19 and competition for the trial participants.
Real-time adaptation to a dynamic European landscape must be made under the conflicting pressures of rapid investigation—where the indication itself increases practical complexities, where there is increasing competition for patients and where there are geographically shifting phases of spread.
Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages:
- Idea/Concept: Understanding options for validating a concept and setting development/regulatory pathways for new medicinal products with a potential to demonstrate benefit for the COVID-19 indication, where there are currently limited data
- Re-purposing: Regulatory pathways including available mechanism for accelerations for re-purposing products where there is some existing data, irrespective of indication or current use
- Rapid Authorisation: Optimising free, fast-tracked scientific advice, utilising PRIME, Accelerated Assessment and Conditional Marketing Authorisation pathways to their best advantage
- Niche Trials: Leveraging focused country selection and submission approaches, considering varying levels of acceptance of trials in different countries
- Expanded Trials: Clinical trial strategies and tactical approaches to accelerate start-up whilst allowing operational flexibility
Join Andrew Masih, BSc, Vice President, Clinical Trial Management, Medpace, James Thomas, BSc (Hons), MA, Director, Regulatory Submissions, Medpace and Tanya Konovalenko, MPharm, RAC, Director, Regulatory Affairs, Scientific and Strategic Development, Medpace in a live webinar on Friday, June 5, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit COVID-19 Product Development and Clinical Trials: Considerations from European Regulatory Perspectives.
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