This is an On-demand recording from October 2019.
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.
Join us for a regulatory professional’s presentation on Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will have learned about:
- 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
Lawrence Liberti, PhD, RAC, head of regulatory collaborations, Center for Innovation in Regulatory Science, Ltd.
Lawrence Liberti, PhD has worked in the fields of pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Liberti 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. Liberti served as the editorial director for the North American operations of ADIS international after which he founded PIA Ltd, a company specializing in regulatory writing and consulting; he co-founded Astrolabe Analytica under which he helped develop, patent and commercialize the Astrolabe Message Mapping System™.
From 2009 to 2019 Liberti has 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 the emerging markets.