14 November · 10:00 – 11:00 EST; 16:00 - 17:00 CET
What Sponsors need to know about the latest FDA Diversity plan guidance?
Gain a comprehensive understanding of the new US Diversity Plan Guidance and its implications for the pharmaceutical and biotech industry. With a focus on key changes, impacts on clinical trials, case studies, and future trends, this session aims to equip pharmaceutical and biotech industry stakeholders with essential knowledge and pragmatic guidance for navigating the evolving regulatory landscape.
Target Audience : Pharmaceutical and Biotech Industry stakeholders, from small to large size companies, with offices mainly based in Europe, the US, ASAP, LATAM and Canada aiming to conduct pivotal Phase 3 trial and register their product in the US.
Speaker details:
Dr Beatriz ROCHA Chief Regulatory Liaison Officer
Dr. Beatriz Rocha has more than 35 years of professional experience that spans from academia and government to industry. It includes clinical practice in anaesthesia and pain management, clinical research, basic research in behavioural pharmacology, and regulatory affairs during the last 18 years, first at Merck Research Laboratories and subsequently at Covance/Labcorp/Fortrea.
Dr. Rocha joined Covance in 2013. Covance became Labcorp Drug Development, which is now Fortrea. She is currently leading the Global Regulatory Affairs team, and lead the Consulting groups directly responsible for the global regulatory strategic development of products (including Regulatory Strategy (non-clinical, clinical and CMC), Clinical Outcomes Assessment (COA), Product Development Team Management), and the required operational support and management. Dr Rocha’s consulting team of regulatory strategists partner with sponsors to help them defining, and implementing, clinical development plans and health economic evaluations that will support their commercial goals in the most expeditious way.
Dr. Rocha has been an active member of CPDD for more than 25 years. She served in diverse committees and at the Board of Directors; she was the Chair of the CPDD Public Policy Committee and currently serves and the CPDD Long-Ranging Planning Committee. She is the Chief Operating Officer of the Cross Company Abuse Liability Council (CCALC).
Teresa Oblak, PhD, Senior Director, Global Regulatory Affairs
Teresa has 15 years of professional experience in drug development—a majority in a contract research organization—spanning regulatory affairs, medical writing, and value demonstration.
Teresa joined Covance in early 2013, which was acquired by Labcorp in 2015 and became Labcorp Drug Development and later spun out into an independent contract research organization, Fortrea, in 2023. At Fortrea, Teresa’s focus is as a Clinical Regulatory Strategist where she provides guidance and input into global clinical development program across drug classes and therapeutic areas, aiding in the achievement of various key regulatory and commercial milestones for sponsors. Her remit and expertise also includes the development of diversity action plans; of which, Teresa and her fellow Regulatory Strategists have championed dozens of Diversity Action Plans in the prior 18 months, partnering with both large and small-sized sponsor organizations to proactively address this codified requirement and articulate goals for increasing enrollment from historically underrepresented populations in clinical trials.
This webinar is sponsored by Fortrea
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CCCMHPIE is the leading national industrial association in China devoted to
promote international trade and investment in the healthcare sector, and
notably the co-organizer of CPHI China. Collaboration with them will
definitely make the session more impactful.
Disclaimer: Whilst TOPRA is running this webinar for Fortrea, this is not an endorsement of Fortrea, Fortrea's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
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