Determining the right regulatory pathway for your drug

Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.

About this webinar

The new EU Clinical Trials Regulation (CTR) is one of the most significant advancements in clinical trial guidance in the last decade. This new guidance has left many of drug developers with questions that could lead to delays in starting or conducting Phase I clinical trials in European Member States.

This presentation delves into the different regulatory requirements, procedures, and timelines based on where you choose to conduct your studies—from the Clinical Trial Authorisation (CTA) in Canada, the UK, and across the EU, to the US Food and Drug Administration’s Investigational New Drug (IND) application.

Key takeaways

Determine the right regulatory pathway for your drug based on the country or regulatory agencies’:

  • Submission requirements
  • Review and submission process
  • Required data
  • Submission timelines
  • Specific advantages.

Our speakers

Leslie Dowling, Senior Director, Regulatory Affairs, tranScrip

Leslie joined Real Regulatory in 2017, which was acquired by tranScrip in 2022 to become tranScrip’s Regulatory Affairs department. She has worked in regulatory affairs since 1997, mainly in human medicines, but also with medical devices and veterinary medicines. She is experienced in managing multiple regulatory projects simultaneously, working in matrix organisations, both within small/medium pharma and as consultant/CRO with small/medium/large pharma clients. Leslie has CTA experience in Phase I to III studies, including first-in-human and paediatric studies, mostly in the UK and the EU, as well as in Eastern Europe, Australia, Canada, Israel, and India. Her Marketing Authorisation Application (MAA) experience includes new MA applications as well as post-registration maintenance and variations, mostly in the UK and EU but also in the Americas, Middle East, Africa, and Asia Pacific. Her therapeutic area experience includes oncology, orphan conditions, neurology, and anti-infectives. Leslie has experience with advanced therapy medicinal products (primarily gene therapies), orphan medicinal products, scientific advice/protocol assistance, paediatric investigation plans, and PRIME application.

Roland Jbeily, Regulatory Affairs Manager, Altasciences

Roland joined Altasciences in 2020, bringing more than seven years of experience in regulatory affairs and compliance for global authorities, such as the FDA, EMA, and TGA, with in-depth expertise in Health Canada’s drug and cannabis regulations. As manager, Roland oversees clinical trial applications to Health Canada for small drug molecules, biologics, natural and cannabis health products, and combo drug-medical devices.

He provides sponsors with strategic guidance on regulatory strategies, gap analysis, consultancy support, and liaison support with Health Canada. He has experience in chemistry, manufacturing and control (CMC), and pharmaceutical manufacturing.

Roland began his career in the QC Lab at Pharmascience as a Chemistry Analyst. From there, he held positions at Accord Healthcare as Regulatory Affairs Specialist, and Canopy Growth Corporation as a CMC Manager for cannabis research products.