PepGen’s Post

I'm excited to share my article in the latest June 2024 issue of PharmaTimes Media Ltd. Written with Advanced Clinical Senior Director, Global Regulatory Affairs, Dr. Mai Mishir, we share some of the challenges in navigating regulatory and safety hurdles in global clinical trials, and how success can be maximised through strategic partnerships. Please give it a read! https://lnkd.in/eYDTJHu3

🌐 The Long and Winding Road: (Some) EU and FDA Issues to Consider With Clinical Trials and Clinical Agreements 🗓️ Save the Date: Wednesday, September 20, 2023 | 11:00 AM – 12:15 PM EDT Dear LinkedIn Community, Join us for an enlightening webinar where we delve into the intricacies of clinical trials and agreements, bringing you insights from both sides of the Atlantic. Hosted by Arnall Golden Gregory LLP Food & Drug co-chair Alan Minsk and featuring the esteemed Taylor Wessing Life Sciences and Healthcare attorneys Dr. Manja Epping and Irina Rebin, this complimentary webinar promises to be an invaluable resource for professionals in the field. 📋 During the webinar, the attorneys will discuss: • Regulatory issues to consider with clinical trials in the U.S. and EU • Typical contractual issues arising in clinical trial agreements • Recommendations to minimize future programs and risks 🙋♀️🙋♂️ Stick around for a Q&A session at the end, where you can engage with our panel of experts and get your burning questions answered. 📚 Professional Development: As professionals, we understand the value of continuous learning. This webinar has been submitted for approval by the State Bar of Georgia and is pending CLE credit for one hour. Please click below to register. 📌 #ClinicalTrials #HealthcareRegulations #Webinar #FDA #EU #LegalEducation #AGGFoodAndDrug #TaylorWessing #ExpertInsights # #LifeSciences #Healthcare #Legalink #Expertise #RiskMitigation

Exciting Session Alert at Pre-Filled Syringes and Injectable Drug Delivery Conference 2024! oin us for a thought-provoking presentation by Steve Hoare, Head of Stds and Regulatory Governance, Secretary, Scientific Director of the BP Commission at Medicines and Healthcare products Regulatory Agency as he delves into "The Regulator as an Enabler for Sustainable Medical Products." Key Takeaways: - Placing patients' interests and priorities FIRST! - Learn about the art of "building compliance in" – how consultation and information play a pivotal role. - Understanding the boundaries: What a medical devices regulator CANNOT do. - Striking the right balance: Legislation, Guidance, Guidelines, and advice. - Get an insider's view on the MHRA's "Net Zero" Policy and the exciting NEXT STEPS towards sustainability. - Don't miss out on this unique opportunity to gain insights into the dynamic landscape of regulatory governance and its impact on sustainable medical products. Secure your ticket here > https://lnkd.in/e9sahMAS

In case you missed our Global Life Sciences Forum, check out this summary of key thoughts and get inspired for next year!

Are you ready to take your regulatory competence to the next level this spring, with Eva Lilienberg, Åsa Holmgren, Marie Gårdmark, Anders Juréus RegSmart Life Science, Elisabeth Augustsson, Stefan Johnn Kenvue and lecturers from AstraZeneca and RegFile AB? 🥝 All fresh new course in Regulatory Strategies! 📍 May 29-30, Stockholm or online ♟ Formed to give you the opportunity and tools to be able to contribute strategically to the company in your regulatory role – whether that is at a research or marketing company. 🗨 “For those of you who want a thorough understanding of the strategic considerations and steps to take in the different stages of the drug development process. E.g. which actions to be taken at the early stages of development? What is the regulatory contribution to the clinical development program? Should you seek authority advice, when and where? A useful course for those working in small companies as well as those working in mid- to big size companies and want to be prepared for the process to take a product to the market and manage its life cycle from a regulatory perspective.” says Eva Lilienberg, lecturer and part of the course program committee together with Kristina Johansson.

Join us for an insightful exploration into the regulatory framework, recent trends, and challenges shaping the landscape of Orphan Drugs, presented by our Regulatory Affairs Specialist Virginia García Muñoz. 📆 April 30th, 3 PM CET ⏳ Duration: 1 hour 🔗Register: https://lnkd.in/dRr2aB_y Within the European Union, the legal framework incentivizes orphan medicinal product development, driven by a commitment to addressing the unmet medical needs of vulnerable patients. Navigating this intricate landscape requires a deep understanding of the legal benefits and obligations, the emerging trends, and the blocking issues. #orphandrug #regulatoryaffairs #orphanmedicinalproduct #productdevelopment

💡 Did you know that sildenafil, the active substance of Viagra, was designated as an orphan medicinal product for the treatment of pulmonary arterial hypertension in 2003? Then, when Revatio (sildenafil 20 mg film-coated tablets) obtained the EU market authorization in 2005, it benefited from 10 years of market exclusivity. This is a clear example of repurposing of an already known molecule for the treatment of an orphan therapeutic indication. If you would like to learn about the current orphan regulation by reviewing some of the most remarkable cases, join me in the next ProductLife Group  x Zwiers Regulatory Consultancy BV webinar.   📆 April 30th, 3 PM CET ⏳ Duration: 1 hour 🔗Register: https://lnkd.in/dRr2aB_y

Blurring Boundaries, what does it mean for the life sciences & healthcare sector? At this year’s CMS Global Life Sciences & Healthcare Forum, we focused on this very theme exploring the convergence of life sciences and law. We received input from industry experts, including Annemiek Verkamman of hollandbio, Charida Dorder, Simon Neill of Johnson & Johnson, Joep Rijnierse of Amgen, Wouter Boon of Utrecht University and Marc Kaptein, M.D. of Pfizer.    We also complemented the industry viewpoints with our own sector specialists including Nick Beckett, Jens Wagner, Ellen Gielen, Dr. Roland Wiring, Gertie Lintjens, Shuna Mason, Gabriela Staber, Romain Alderweireldt, Christoph Willi and Jörn Witt.   Find out more about Blurring Boundaries - Exploring the convergence of life sciences and law here: https://lnkd.in/e5XCi2XS   #CMSlaw #law #innovation #pharmaceuticals #medicaldevices #biotechnology #data #globalisation #lifesciences #healthcare

Industry-changing drug pricing regulations were in the spotlight at Informa Connect Life Sciences' MDRP Summit in Chicago last month. From IRA implementation to an invigorated government approach to drug pricing, esteemed experts guided attendees through a dynamic and complex drug pricing landscape. Kalderos was there to listen and contribute every step of the way — check out our blog to see MDRP Summit’s biggest themes and takeaways. https://lnkd.in/gRhM27Eb #MDRPSummit

🔔 Don't miss Worldwide Clinical Trials' upcoming webinar on the advantages of early and continual #regulatory engagement. Industry-leading regulators from biopharma and CRO backgrounds will engage in a not-to-be-missed conversation, sharing vital strategies for seamless regulatory navigation. 🔍 Learn to avoid common pitfalls that could jeopardize submission deadlines, gaining invaluable insights into safeguarding project timelines. 💡 By sharing lessons learned and expert strategies, the speakers will equip you with the knowledge needed to streamline your regulatory journey, ensuring overall success. ➡️ Learn more and register here: https://buff.ly/3TnMk2y 🌟 Expert speakers: Linda Bowen, MSc, RAC, FRAPS Aman Khera EMBA FRAPS FTOPRA #ClinicalTrials #DrugDevelopment #CRO #RegulatoryApproval #RegulatoryAffairs #RegulatoryCompliance