Speed vs. Safety: How Regulators Are Sizing Up Evidence Today

Life Sciences, Clinical Trials, Drug Discovery & Development, Drug Safety,
  • Monday, October 26, 2020

In drug development, there is always pressure to move quickly, and with today’s push to develop treatments and vaccines for COVID, those pressures are exacerbated. From sponsors and investors to investigators and regulators, everyone is trying to balance the dual needs for speed and safety.

The places where they find success are likely to change drug development forever.

Adopting decentralized trials and embracing real-world data allows COVID (and other) trials to proceed at a time when typical site visits are fraught. Once global regulators are secure that even under these new circumstances, the data are still valid and clean, these processes are likely to be more widely implemented. In the meantime, sponsors should be confident about working closely with regulators to understand potentially shifting requirements and to build a strong regulatory strategy.

In this webinar, the speakers will ground their predictions for the future in the historic response of regulatory bodies to epidemics, then explore recent shifts in the regulatory environment in response to COVID and the resulting new efficiencies in drug development.



Linda McBride, Executive Director, Regulatory Affairs and Compliance Regulatory Professionals, a division of Premier Research

Linda McBride is the executive director, regulatory affairs and compliance, at Regulatory Professionals, a division of Premier Research. Previously she was the head of regulatory affairs and clinical compliance at Revance Therapeutics. She began her more than 30-year career in the pharmaceutical industry as a research pharmacist with Novartis Consumer Health and moved to regulatory affairs 22 years ago at Bayer, since then she has held positions within regulatory of increasing responsibility at Enturia, Cogentus and Gilead Sciences. Her therapeutic area expertise includes analgesia, anti-infectives, cardiorenal, dermatology, neurology, oncology and pulmonology with small molecules, biologics, combination products and over-the-counter products. She has a B.S. in Pharmacy and earned a Regulatory Affairs Certification (RAC) for the US. She is a member of the Regulatory Affairs Professionals Society and a member of their Editorial Advisory Committee.

Message Presenter

Daniel Semere, Senior Regulatory Submissions Manager

Daniel is a Senior Regulatory Start-Up Manager, responsible for managing First in Human and phase I-IV trials in the EU, North America and Asia Pacific regions. He is responsible for the global regulatory start-up strategy for each given projects or products in various areas such as endocrinology, paediatrics, rare disease, cardiology, neurology, rheumatology and oncology.

With More than 13 years experience as Regulatory and Study start up manager, Daniel has worked in large pharmaceutical companies and other CROs contributing to many successful approvals.

Daniel is also overseeing the UK  Study Start Up team and driving the regulatory/start up timelines and processes.

Message Presenter

Who Should Attend?

Managers and above at biotech and specialty pharma companies with job functions including but not limited to:

  • Clinical Operations
  • Medical Affairs
  • Project Management
  • Regulatory Affairs

What You Will Learn

In this webinar, regulatory experts will share:

  • Current regulatory trends and the role of CTAP (Coronavirus Treatment Acceleration Program)
  • Strategies to address regulatory concerns in today’s COVID environment
  • The lasting impact of COVID-era changes on the clinical trial landscape

Xtalks Partner

Premier Research

Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.

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