COVID-19 Product Development and Clinical Trials: Considerations from European Regulatory Perspectives

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

Keys to success include engagement with European regulatory authorities (both European Medicines Agency and National Competent Authorities), maximizing existing mechanisms and understanding and executing the extraordinary COVID-19 specific measures now in place. Ultimately, this can save time and cost to expediting development and to achieve our common goal.

Speakers

Andrew Masih, BSc, Vice President, Clinical Trial Management, Medpace

Andrew Masih is a Vice President at Medpace and has been with the company since 2007. Based in London, Andrew has over 15 years of experience in clinical research and has worked across therapy lines including oncology. Andrew supports global operations at Medpace and is a key leader for Europe supporting high priority clients to ensure successful delivery of their programs.

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James Thomas, BSc (Hons), MA, Director, Regulatory Submissions, Medpace

James Thomas has a combined scientific (microbiology and infection with focus upon emerging infections), legal (Masters in biotechnological law and ethics) and ethical background to conduct and oversee submissions and approvals in 50+ countries from Phase I to IV over the last 15 years. His additional interactions are with regulatory authorities, government policy stakeholders across the spectrum of therapeutic indications and trials types i.e. medicines, radiopharmaceuticals, biosimilars, medical devices, combination products and advanced therapies. This diverse experience gives him a unique perspective on regulatory and operational delivery.

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Tanya Konovalenko, MPharm, RAC, Director, Regulatory Affairs, Scientific and Strategic Development, Medpace

Tanya Konovalenko has over 25 years of international experience in drug development of small molecules and biologics through all phases of clinical research, authorization and post approval. She has worked in Canada and Switzerland and has served as a principal interface for interactions with major regulatory agencies including EMA, FDA, Health Canada and various National Competent Authorities in Europe. Tanya has extensive experience with pre-submission meetings, interactions and negotiations with the agencies, and has designed and executed effective global regulatory strategies, submission review and post approvals.

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