To be successful and stay competitive, pharma and biotech companies often look to expand into new markets. Expansion introduces new challenges with regulatory compliance and data integrity regardless of expansion type. Tracking and locating all the key pieces of information needed to successfully launch in new markets can be time-consuming and error prone. Often, nuances of regulations and specific requirements are missed when they vary so greatly in each potential market. You need a strategic advantage to increase your success and compliance in new markets.
– Regulatory complexity and requirements of divergent markets
– Common challenges in establishing relationships with local regulatory bodies
– Considerations for inspection, stability requirements and track-and-trace systems
– Proper vetting of reimbursement policies and protection of intellectual property
– Best practices to optimize regulatory compliance in new markets
Who Should Attend?
– Regulatory Affairs Professionals with more than 5 years’ experience
– RA managers and directors
– QA managers and directors
Speakers: Lawrence Liberti, PhD, RAC, head of regulatory collaborations, Center for Innovation in Regulatory Science Ltd.
Lawrence Liberti, PhD began his career at Wyeth Laboratories working in product development, then as a regulatory writer in clinical R&D, and manager of safety surveillance in medical affairs. From 2009 to 2019 Liberti served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science Ltd., forming part of Clarivate Analytics). In 2019 he transitioned to his current position. Liberti has been actively involved in promulgating best practices in the regulatory aspects of medicines development, especially in emerging markets. He received both his Bachelor of Science in pharmacy and Master’s degree in pharmacognosy from the Philadelphia College of Pharmacy and Science (now the University of the Sciences in Philadelphia). Liberti received his doctorate in International Regulatory Policy through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation based in the Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands. He attained the status of Regulatory Affairs Certified (RAC) with the Regulatory Affairs Professional Society.