regulanet®

𝗧𝗵𝗲 𝗔𝗰𝗰𝗲𝘀𝘀 𝗖𝗼𝗻𝘀𝗼𝗿𝘁𝗶𝘂𝗺 𝗶𝘀 𝗯𝗲𝗰𝗼𝗺𝗶𝗻𝗴 𝗮𝗻 𝗶𝗻𝗰𝗿𝗲𝗮𝘀𝗶𝗻𝗴𝗹𝘆 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗽𝗮𝘁𝗵𝘄𝗮𝘆 𝗳𝗼𝗿 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝘁𝗼 𝗯𝗿𝗶𝗻𝗴 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 𝘁𝗼 𝗺𝘂𝗹𝘁𝗶𝗽𝗹𝗲 𝗶𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗺𝗮𝗿𝗸𝗲𝘁𝘀 𝘁𝗵𝗿𝗼𝘂𝗴𝗵 𝗮 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵. In this article, co-authored by Wendy Dodd (regenold UK & Ireland), Johanna Hann (Pharma To Market), Manuel Vögtli (Medius AG) and Carolyn Hosannah (Intertek), we explore how the Access Consortium works, the benefits of work-sharing, and the key considerations for sponsors planning global regulatory submissions. Through the regulanet® network, trusted regulatory partners combine local expertise with centralised project management to guide clients through every stage of the Access submission process. By delivering a coordinated regulatory strategy across participating markets, the network helps reduce complexity, improve efficiency, and support timely access to pharmaceuticals for patients around the world. Read the full article here: https://lnkd.in/eMEHBVs7 #AccessConsortium #RegulatoryAffairs #LifeSciences #DrugDevelopment #GlobalRegulatory

We are pleased to announce that Pharma To Market is now an official member of regulanet® This membership reflects our continued commitment to collaboration, innovation, and excellence within the pharmaceutical and life sciences industry across the APAC region and globally. By joining regulanet®, we look forward to contributing to industry discussions, strengthening partnerships, and supporting advancements in regulatory affairs and pharmacovigilance. This membership also expands our global reach and creates greater opportunities for our clients through enhanced industry connections, broader market insights, and increased access to global expertise and collaborative networks. We are excited about the opportunities this membership will bring for our team, clients, and industry partners as we continue to support growth and innovation across the healthcare sector #RegulatoryAffairs #Pharma #GlobalHealth #Networking 

Recapping regulanet® Conference… regulanet® is a network of independent regulatory affairs consultancies with representation in over 90 countries throughout the world. Founded in 2001 by regenold GmbH, regulanet® offers services to a wide variety of national and international healthcare and pharmaceutical clients. Once a year, all stakeholders meet in Badenweiler to discuss ongoing regulatory topics. While I had the pleasure to refer about data protection in the age of AI, I really enjoyed all the knowledge shared at the conference. Outcome? One opinion: The legislator is requested to define clear regulatory frameworks for the collection, processing, and use of health and medical data within artificial intelligence systems. Let‘s see how & if the DOP will help out here 💡 This years regulanet® conference was a great success, which makes me even more proud, as the host of the event is my client regenold GmbH. Thanks a lot for the invitation Maximilian Regenold Luise Teml Elia Balint Alexander Klink Thanks also to DataGuard who enabled this trip 🙏🏻

Great to participate at the regulanet® conference together with fantastic colleagues and peers from across industries. Always meaningful conversations. Always valuable connections. Thank you regulanet® for creating the space where real collaboration starts. Looking forward to what comes next. #LINK Medical #regulanet® #GlobalRegulatoryNetwork #RegulatoryAffairs #Pharmacovigilance #Collaboration #KnowledgeSharing #ProfessionalNetworking #GlobalPartners

It’s been a brilliant few days in Badenweiler for some of the JensonR+ team at the 25th Annual regulanet® Conference. It’s a real privilege to be part of such a well organised event, engaging in insightful discussions, knowledge-sharing, and connection across the regulatory, pharmacovigilance and quality assurance landscape. Huge thanks to regulanet® for bringing everyone together and creating such a valuable opportunity to learn, collaborate, and reflect on the future of our industry. We’re heading home inspired, energised, and full of ideas. At JensonR+ we are proud to be part of such a dedicated and passionate network. #Regulanet #ProfessionalDevelopment #Networking #Learning #Collaboration #PartnerOfChoice

Imagine being a statistician and arrive on a conference focussing on Regulatory Affairs in Pharma. ... that just happened a few days ago to me ... and I loved it :-) How little did I know about this field and how much did I learn... and after having attended tremendous talks, participated in fruitful discussions and witnessing extraordinary exchange during three inspiring days in Badenweiler, it broadened my view soo much. I cannot even say which contribution was the most influential (yet?) but I want to thank Dr. Anna Resch, Dr. Daniel Kapfer, Marco Virgolin, PhD, Nicolas Gengenbacher, PhD and Dr. Johannes Seitz for their presentations, talks and discussions, and foremost Maximilian Regenold for his invitation and giving me the opportunity to attend this remarkable regulanet® Conference. Looking forward to attending next year already.

What an incredible week in Badenweiler! Our management team Johanna Hann, Nick Ward and Joelle Chia connected with regulatory and pharmacovigilance and other professionals from across the network and we are energized by the collaborative spirit and innovative thinking. The networking opportunities were invaluable – from poster sessions to interactive discussions with experts tackling similar regulatory challenges worldwide. AI in pharma was a central theme throughout, from regulatory operations to making AI tools inspection-ready, with practical implementation insights particularly relevant to our work. We were honored to present on leveraging EU approvals for expedited pathways in Australia and Singapore, and to share our experience implementing AI tools in our operations. Thank you to the regulanet® team for the invite and superb organisation and all participants for creating such a rich learning environment! #RegulatoryAffairs #Pharmacovigilance #AI #APAC #Regulanet2026

At the regulanet® Conference, I had the pleasure of co moderating the Special Interest Group on Health Technology Assessment together with Daria Mari. We welcomed a strongly international group of participants and kept a clear focus on regulatory strategy and the practical implications of the new HTA rules. The impact is becoming very clear. Earlier and more intensive collaboration across regulatory, clinical, and market access teams is essential if we want not only a marketing authorisation, but also a strong HTA outcome that translates into real access. I also took away valuable insights into how regulatory bodies are already using AI in day to day work, from supporting document intake and triage to accelerating consistency checks and signal detection workflows. Beyond the core sessions, the conference offered strong thought starters and practical examples of what can help the industry move faster. Start ups like Intrepid and Explainable AI sparked useful discussions, alongside tangible applications of AI in statistics that can strengthen evidence generation and decision making. It is always a pleasure to have a rigorous exchange with familiar faces and new minds alike. Thank you for the invitation Maximilian Regenold. #regulanet #regenold #SARTICON

On site at the 25th Annual regulanet® Conference in Badenweiler Our Managing Director Andreas Kranzusch is currently attending the 25th Annual regulanet® Conference. The conference brings together regulatory and clinical development professionals from across the life sciences sector. Clinical development and regulatory pathways are closely linked to financial planning and risk considerations. In this context, part of our expertise addresses these aspects through financial tracking and risk mitigation for clinical studies in biotech. Looking forward to ongoing exchanges during the conference. regulanet® regenold GmbH #LifeSciencesIndustry #ClinicalOperations #RegulatoryConsulting #BiotechStartups