The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved healthcare outcomes for patients. The Regulatory, Compliance and Quality (RCQ) track planned for the 2024 ISPE Annual Meeting & Expo, taking place 13-16 October, in Orlando, Florida, USA. will feature industry and regulatory experts in a variety of topic areas.
The sessions in the RCQ track promise to provide an enlightening experience, offering a platform for an open exchange of ideas and experiences from industry leaders and regulators.
The sessions cover a range of topics within the regulatory landscape of AI in healthcare and the pharmaceutical industry, including the global regulations of AI in medical devices, the integration of AI/ML in GMP, and the challenges and opportunities this presents. Sessions will also discuss the role of translational technologies and precision medicine in developing new standards and research methods, the transformative impact of physiologically based biopharmaceuticals modeling (PBBMs) in drug development and manufacturing, and the proposed shift towards a "one-click" submission process using AI and digital authoring to meet the growing demand for faster regulatory timelines.
Attendees will learn about the US Food and Drug Administration’s (US FDA) approach to complex APIs for generic drugs and the "totality-of-the-evidence" used for regulatory assessment. Changes in global in-country testing requirements of recent years will be presented, focusing on registration and import testing. Experts will also offer a novel perspective on interpreting compliance data, integrating data analytics with legal insights to provide actionable knowledge for navigating the complex regulatory environment.
Sessions will also explore the significance of ICH guidelines, such as ICH Q12 and ICH Q2(R2)/Q14, and their role in advocating for a science- and risk-based approach to lifecycle management as well as how organizations can enhance their quality risk management programs by transitioning towards a patient-centric strategy, aligning risk portfolios with regulatory guidelines to improve patient safety and product quality.
Professionals and regulators in the industry are encouraged to attend. Participation from various professionals across the industry and around the world will add great value to the discussion, and the sessions will be both informative and inspiring. Please join ISPE for this opportunity to enhance the industry’s understanding and contribute to the advancement of the pharmaceutical industry.
Special Highlight: Fireside Chat with Emer Cooke, EMA’s Executive Director
The authors are thrilled that European Medicine Agency’s (EMA) Executive Director Emer Cooke will engage in a fireside conversation with ISPE. Ms. Cooke’s experience and insights in the pharmaceutical and regulatory domains will offer valuable viewpoints on the present industry challenges and opportunities.
Global Regulatory Town Hall
The upcoming event is set to debut a highly anticipated Global Regulatory Town Hall, bringing together distinguished individuals representing prominent global regulatory authorities, including the US FDA, EMA, and Health Canada, as well as industry experts from Gilead, Pfizer, and Spark Therapeutics. This exclusive event will focus on addressing critical topics that are indispensable for the industry's future, including mutual reliance, advanced modeling, the role of AI/ML in the pharmaceutical industry, and the intricacies of supply chain management. This forum will provide an invaluable opportunity to engage in crucial conversations, gain insights from thought leaders, and actively contribute to shaping the future of pharmaceutical regulation and innovation. This is an amazing opportunity for anyone interested in participating in the town hall, as it provides the chance for you to ask a question to the panelists.
Engage with Industry and Regulatory Leaders
Participating in this exceptional event provides attendees a distinct chance to actively join these crucial conversations to explore the role of innovation in driving progress and cultivating a collaborative environment to help shape the pharmaceutical industry's future. Attendees will be able to delve into the potential of collaboration to boost efficiency without compromising safety standards and explore the challenges and opportunities presented by adopting AI and ML in the industry, along with the regulatory frameworks that guide this transition.
Collaboratively, attendees will have the opportunity to come together to tackle pressing challenges facing the pharmaceutical industry, optimize supply chain management, and implement strategies to guarantee timely access to life-saving medications, ensuring that the sector continues to lead in healthcare innovation. Pharmaceutical companies, regulatory bodies, and healthcare professionals can collectively meet patient needs by streamlining processes, reducing bottlenecks, and improving distribution networks. Regulatory agencies are pivotal in ensuring compliance, maintaining public trust, patient safety and quality standards, and expediting drug approval.
With that, the authors extend a warm invitation to the 2024 ISPE Annual Meeting & Expo, a dynamic platform to exchange ideas, develop partnerships, and shape the future of healthcare. Active participation from across the pharmaceutical industry can help establish a healthier, more innovative, and more accessible future for all, and ISPE eagerly anticipates involvement from all in this transformative journey.
Now, for a limited time, attendees can save $300 on the 2024 ISPE Annual Meeting & Expo, using the promo code: 24AM300*
