Arnold & Porter Global Life Sciences

Counsel and compliance personnel at pharmaceutical and biotech companies in the U.S. are often involved in establishing and advising European operations. The European market offers substantial opportunities for U.S. companies, but also raises complex questions for product authorization and market access — understanding and addressing these questions early in the process can prevent delays, unsuccessful launches, and later compliance problems. Join us for a unique, one-day program designed to provide U.S. lawyers with an overview of EU/UK biopharmaceutical regulation and compliance. Our European life sciences team will present an interactive program reviewing key topics relevant to the development and commercialization of medicinal products in Europe. Whether you’re new to the EU/UK regulatory frameworks for medicinal products or a veteran of the industry wanting a refresh, our Europe-based attorneys will walk you through the steps required to prepare for and execute a successful product launch. Learn firsthand from professionals who have helped companies large and small prepare to bring their products to the European market. We’ll cover the evolving framework for the regulation of medicinal products in the EU and UK, key considerations for clinical development, and strategies for commercialization. We will also provide an overview of issues relevant to medical devices used with medicinal products, EU supply chain considerations, pricing and reimbursement, EU antitrust considerations, and the new product liability regime. Register here ➡️ https://lnkd.in/e2T66t5n #Biopharma #Compliance #LifeSciences #Regulatory #ProductLaunch Jackie Mulryne | Alexander Roussanov | Adela Williams | Niels Christian Ersbøll | Ewan Townsend

China’s First Official Anti-Corruption Guidance for the Healthcare Industry Recently, the State Administration for Market Regulation (SAMR) issued the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines). These Draft Guidelines were published for public comment, due by Sunday, October 20, 2024. While China’s public comment system is still developing, the Draft Guidelines provide valuable insights into regulators’ expectations and are a milestone development in the country’s anti-corruption regulatory framework. Read our latest Advisory for informal translations of the guidelines and a high level overview of key content ➡️ https://bit.ly/4eK8eGK #FCPA #AntiCorruption #LifeSciences #China John Tan | Siyi Gu

Don’t miss out! Counsel and compliance teams at U.S. pharmaceutical and biotech companies often play a crucial role in setting up and working with European operations. With the European market offering significant opportunities, it's vital to understand the complex regulatory questions that can impact product authorization and market access early on. Join our one-day program designed to give U.S. lawyers an overview of EU/UK biopharmaceutical regulation and compliance. Our European life sciences team will guide you through the steps to ensure a smooth product launch in Europe, covering key topics like regulatory frameworks, clinical development, commercialization strategies, and more. Whether you're new to the EU/UK regulatory landscape or looking for a refresher, this interactive program is for you. Secure your spot now: https://bit.ly/3zLNXS4 Jackie Mulryne | Alexander Roussanov | Adela Williams | Niels Christian Ersbøll | Ewan Townsend #Biopharma #Compliance #LifeSciences #Regulatory #ProductLaunch

Stay informed on the latest developments in U.S., EU, and UK healthcare in the latest issue of our Virtual and Digital Health Digest. This edition covers key regulatory updates, health fraud, reimbursement news, and more! Highlights Include: • U.S. News: FDA’s CDER forms an Artificial Intelligence Council, aligning with the Biden administration's AI executive order to ensure drug safety and effectiveness. • EU/UK News: France’s health regulator delivers a notable verdict on a digital therapeutic, and the UK NICE issues guidance on the use of AI in health technology assessments. • Corporate Transactions: Digital health companies continue consolidating for enhanced technological capabilities. • Provider Reimbursement: CMS finalizes a new alternative payment model and offers telehealth waivers for improved patient care. Don’t miss these essential updates, including fraud and abuse cases, groundbreaking corporate transactions, and more insights that could impact the healthcare landscape. Click here to read the full digest ➡️ https://bit.ly/3XGPrVq #DigitalHealth #AI #Telehealth #Reimbursement

We were thrilled to host our UK & EU Annual Life Sciences Conference, bringing together in-house regulatory and legal counsel to discuss the latest developments in the industry. From the EU Pharma Package and AI Act to Brexit and market access updates, our speakers delivered timely insights into key regulatory changes. A big thank you to all who attended, engaged in discussions, and joined us for networking throughout the day. We look forward to seeing everyone again next year! #LifeSciences #RegulatoryUpdates

Here is today’s interview of Daniel Kracov and Mahnu Davar as they share the “secret sauce” of Arnold & Porter’s Food and Drug Law practice. Click here and enter the passcode: https://lnkd.in/g3Ny3ZeG Passcode: 1Q+S7.mJ #lawfirms #secretsauce #fda #lawpractice #lawyers #attorneys

Last week, our U.S.-based Life Sciences & Healthcare Regulatory practice attorneys came together for more than just a retreat—it was a chance to give back. In partnership with Impact 4 Good and the Boys and Girls Club of Greater Washington, attorneys spent time building bikes for local youth who have been hard at work serving their community this summer. These bikes will help the kids travel to school and the Boys & Girls Clubs independently, furthering their opportunities for growth and their commitment to ongoing service.   The Boys and Girls Club of Greater Washington serves over 12,000 kids across 26 branches, making an incredible impact on youth in the region. We’re proud to play a small role in supporting such an important organization and the bright futures of these kids.

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Looking forward to our Future Forum Medicines Bootcamp next week, where we will provide an overview of the regulatory framework for medicine in the UK and EU. There is still time to sign up - link in the comments. See you there! The Life Sciences Future Forum is a group established to provide training and networking opportunities for in-house junior and mid-level lawyers in the life sciences industry. However, all seniorities are welcome! Arnold & Porter Global Life Sciences

Join us in South San Francisco on September 26, where our Life Sciences and Healthcare Regulatory team will be discussing regulatory, compliance, and privacy “hot topics” relevant to the life sciences industry. The day will be built around four topics, presented in an interactive panel format and accredited for CLE: • FDA regulatory trends from R&D to AdPromo • Patient access and the attendant compliance issues to watch • Assessing the impact of the Inflation Reduction Act and other key pricing and contracting developments • Emerging enforcement themes and lessons for compliance and privacy programs Over lunch, our panel will discuss the implications recent Supreme Court decisions, including Loper Bright, Corner Post, and Jarkesy, will have on the life sciences industry and how companies should adjust their regulatory and litigation strategies. Whether you are at an established biotechnology company looking for a quick hit on current industry risk management issues, or you are helping your business clients prepare to launch your company’s first product, we think you will find this program of value. Learn more and register today ➡ https://bit.ly/4dMu8Zf Gina M. Cavalier | Mahnu Davar | Abeba Habtemariam | Kristin Hicks | Liz Lindquist | Jami Mills Vibbert | Howard Sklamberg