April 28th Webinar: Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19

Speaker(s): 
Demetrius Carter, Senior Vice President, Services Operations, Regulatory Services – Synchrogenix, a Certara Company
Elaine B. Taylor, Vice President, Regulatory Strategy and Policy – Synchrogenix, a Certara Company
Date: April 28, 2020
Time: 11:00 am ET
Duration: 1 hour
The impact of the COVID-19 pandemic is just now being understood by the drug development community. COVID-19 has the potential to negatively impact critical path activities such as patient recruitment, patient safety and ensuring data integrity. As a result, Clinical Developers should actively review their planned regulatory filing strategies to determine if modifications are required. Many of the leading regulatory agencies, including the FDA, EMA and MHRA, have recently issued new guidance as it relates to mitigating actions sponsors should take.

COVID-19 has the potential to directly impact the timing, quality and key messages in your regulatory filing. Please join Synchrogenix as we discuss mitigation strategies and best practices that you can begin implementing now. Synchrogenix can leverage our deep scientific, therapeutic and operational expertise to support critical path regulatory strategies for your program.

In this webinar:

  • Review mitigation strategies for protecting patient safety and the timely collection of clinical data
  • Proven strategies for ensuring data integrity
  • Considerations for review with IRB/IEC
  • Compare and contrast COVID-19 guidance from the FDA and EMA
  • Assessing the impact of COVID-19 on Integrated Safety and Efficacy analysis
  • Key next steps to consider in modifying your marketing application strategies
demetrius.pngDemetrius Carter has more than twenty years of experience across the drug development spectrum. Currently, Demetrius serves as the Senior Vice President, Regulatory Sciences at Synchrogenix, a Certara company. In this capacity, he is globally responsible for their Regulatory Writing, Submissions and Operations teams. His team is accountable for providing technical expertise across the regulatory continuum, leading to the acceleration of regulatory decision-making.
elaine2.pngElaine B. Taylor has more than 30 years of experience in the pharmaceutical industry and has extensive experience developing and providing strategic guidance and regulatory advice at all stages of product development. Currently, Elaine is Vice President, Regulatory Strategy and Policy at Synchrogenix, a Certara company where she leads the Regulatory Strategy group. Her group provides global regulatory strategy, consulting, and submission support from early stage (preclinical) to post-marketing.

Leave a Reply

Your email address will not be published. Required fields are marked *