Newsletter: Project Orbis, Outsourcing Oversight, RAPS Convergence

As the clock ticks down to the implementation of the EU Joint Clinical Assessment, attention must turn to what is known, what questions still need to be answered and how best to prepare. Meanwhile, market access is just one issue that companies must tackle at the country and local level, with significant regulatory differences placing massive demand on companies at the local level, raising questions about the current local affiliate model. These and other regulatory issues impacting the industry will be discussed at the TOPRA Medicines Symposium in Lisbon in October and will continue to be focal considerations for our regulatory experts.

Gearing up for the JCA: Understanding the changes and their implications

The European Union is preparing to streamline and strengthen its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA). The mandatory new process will begin in January 2025 with oncology drugs and advanced therapy medicinal products (ATMPs), followed by orphan drugs in January 2028 and all remaining drugs registered with the European Medicines Agency (EMA) by 2030. Industry needs to prepare itself for the JCA by understanding what it is, what it means and what to expect for 2025 and beyond. Learn more from leading market access experts across the industry.

Reshaping the affiliate model in a complex global regulatory environment

Rapid globalization heightens the imperative for the pharmaceutical industry to become more operationally agile in order to successfully navigate a complex regulatory environment. Crucially, that will require considering the sustainability of the affiliate model and how to address the many roles and activities carried out by the local affiliate.?Download the white paper ?to gain insight into the issues impacting the affiliate model and strategies to balance global and local processes.

TOPRA annual symposium to explore important regulatory and legislative developments

The annual TOPRA Human Medicines Symposium will be held in Lisbon in October, bringing together regulators and industry leaders to discuss the biggest issues and initiatives impacting innovation and regulatory activities. Speakers will explore the new EU pharmaceutical legislation and how it will impact activities, regulatory strategy aimed at improving the odds of success, and the evolving clinical trials landscape. Join PharmaLex at Booth #16 from 23 to 25 October to discuss these and other important regulatory issues. Learn more.

Navigate pharma compliance challenges for successful promotional strategies: webinar

A successful product launch in today’s highly challenging climate requires targeted, cost-effective marketing and outreach campaigns. At the same time, companies need to understand and adhere to strongly regulated promotional activities, designed to prevent inaccurate, misleading, or unethical promotion of medicine. Join our webinar, which brings together speakers from PharmaLex and Innomar Strategies, both part of Cencora, to explore strategies for successful product launches.

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