Regulatory strategy at BIO‑Europe 2026
Nov 9–11, 2026 Cologne, Germany ~5.8k attendees Website
30 organizations at BIO-Europe 2026 present work in regulatory strategy: 15 drug developers, 8 academic, government and non-profit bodies and 7 service providers. Between them they bring 64 presentations to the program. Most represented: Merck KGaA (9 on the program), Bayer (7 on the program), European Medicines Agency (5 on the program). 21 of them have their own page in this guide. As of Sep 29, 2026.
Format
Top represented
Showing 1–11 of 30 organizations
| Organization | BIO-Europe 2026 Attendance |
|---|---|
Merck KGaA Darmstadt, Germany | ◆Platinum Sponsor |
Science and technology company active in healthcare, life science and electronics; operates as EMD Serono and MilliporeSigma in North America. | Talk Mon Nov 9 15:00–16:15 Merck's EMEA Advance Biotech Grant Program Five young biotech companies pitch their science to Merck, competing for a grant that helps them bring a product to market. Panel Mon Nov 9 13:00–13:45 Open Innovation in Action: How Pharma Is Rewiring the Drug Discovery Ecosystem How big drug companies share their collections of test molecules and data with outside scientists to speed up early drug discovery. Panel Tue Nov 10 14:00–14:45 Immunology under the microscope: New frontiers What is new in drugs for autoimmune and inflammatory diseases: emerging targets, recent trial results, and where companies are investing and partnering. Panel Tue Nov 10 16:00–16:45 Unlocking Clinical Trial Systems How EU clinical trial rules and a planned EU biotech law affect trial approval times, and whether Europe can speed up safely. Panel Wed Nov 11 09:00–09:45 From NAMs (New Approach Methodologies) Innovation to Regulatory acceptance: Accelerating human-relevant modelling How lab models built on human biology, from organs-on-chips to AI computer models, can speed drug development and win regulators' acceptance. |
Bayer Leverkusen, Germany | ◆Platinum Sponsor |
Life sciences company with pharmaceuticals, consumer health and crop science divisions. | Talk Tue Nov 10 09:00–09:30 An Outlook into the Year 2050: Navigating the Future of Efficiency and Innovation How AI, global expansion and patient community outreach may reshape the way clinical trials are run, and what to change now to prepare. Panel Tue Nov 10 15:00–15:25 Inside the Incubator: What It Really Takes to Build a Biotech Company Today What incubators backed by big drug companies look for in young biotechs, and how they help founders with money, advice and partners. Panel Tue Nov 10 17:00–17:45 Resilient by Design: Reinventing Biopharma Alliances in a Fragmenting World How drug companies are reshaping research and manufacturing partnerships to stay reliable as political tensions and supply chain risks divide the world. Business of BiotechBiomanufacturing Strategy Panel Tue Nov 10 16:30–16:55 The Role of Innovation in Biopharma Growth How new ideas and technologies drive growth for drug companies, and how to keep innovating while scaling up, with real examples. Panel Wed Nov 11 10:00–10:45 AI Regulations: Driving Innovation While Navigating Compliance What rules cover AI in drug development, where European and US regulators agree, and how rules could help rather than hinder innovation. Panel Wed Nov 11 09:00–10:00 Collaborative Innovation in CDMO Partnerships How drug companies and contract manufacturers develop new therapies together, with examples of what makes these partnerships work and where they struggle. |
European Medicines Agency Amsterdam, Netherlands | |
EU agency that evaluates and supervises medicines for human and veterinary use. | Panel Mon Nov 9 11:00–11:45 Unlocking Pharma’s Productivity Potential Why developing medicines keeps getting costlier and slower, and whether AI and research sourced from other companies can make drug companies more productive. Business of Biotech Panel Tue Nov 10 13:00–13:45 Aligning with Regulators to Propel Innovation What help and incentives the European Medicines Agency offers developers of new treatments, and how to use them on the road to approval. Panel Tue Nov 10 14:00–14:45 Harnessing Regulatory Sandboxes to Drive Innovation in Novel Therapeutics & Technologies How regulatory sandboxes, where regulators let new products be tested under adjusted rules, could support new therapies and health technologies in Europe. Panel Wed Nov 11 10:00–10:45 AI Regulations: Driving Innovation While Navigating Compliance What rules cover AI in drug development, where European and US regulators agree, and how rules could help rather than hinder innovation. Panel Wed Nov 11 09:00–09:45 From NAMs (New Approach Methodologies) Innovation to Regulatory acceptance: Accelerating human-relevant modelling How lab models built on human biology, from organs-on-chips to AI computer models, can speed drug development and win regulators' acceptance. |
Johnson & Johnson New Brunswick, NJ | ◇Silver Sponsor |
Healthcare company developing innovative medicines and medical technologies; its Innovation unit partners with external researchers and start-ups. | Panel Mon Nov 9 16:15–17:00 Building the Next Global Biotech Hubs: What Makes an Innovation Ecosystem Work? What makes a region a strong biotech hub, from talent, labs and funding to links with global drug companies. Panel Tue Nov 10 10:00–10:25 Regulatory Updates for Orphan and Paediatric Medicines How updated EU drug laws change the rewards for rare-disease and children's medicines, such as longer protection from competing copies. Panel Wed Nov 11 10:00–10:45 Envisioning the future of ophthalmology What new data show about treatments for retinal disease, glaucoma and other eye conditions, and where investors see the most promise. Panel Wed Nov 11 13:00–13:45 What's Next for Biomanufacturing Strategies? Where the manufacturing of biological medicines is heading, from sturdier supply chains and industry mergers to AI and new ways to scale up. |
AstraZeneca Cambridge, United Kingdom | |
Global pharmaceutical company developing medicines in oncology, cardiovascular, renal, respiratory, immunology and rare diseases. | Panel Mon Nov 9 17:00–17:45 AI in the Lab: Why Greater Efficiency Could Mean More Drugs, Not Fewer Scientists Why AI that forms hypotheses and guides experiments could mean more drug candidates, not fewer scientists, and how to pick which to pursue. Ecosystem InnovationBusiness of Biotech Panel Tue Nov 10 16:00–16:45 Unlocking Clinical Trial Systems How EU clinical trial rules and a planned EU biotech law affect trial approval times, and whether Europe can speed up safely. Panel Wed Nov 11 11:00–11:30 Sustainability & Innovation: Transforming Biopharma Partnerships for a Greener Future How drug companies, smaller firms and suppliers can team up to cut supply chain carbon emissions and bring greener technologies to industrial scale. |
EUCOPE Brussels, Belgium | |
Trade association representing small and mid-sized innovative pharmaceutical and biotech companies in Europe. | Panel Tue Nov 10 10:30–10:55 Addressing Unmet Medical Needs in Europe’s Evolving Pharmaceutical Landscape How regulators judge which diseases lack good treatments, which faster approval routes apply, and whether recent EU drug law changes have helped. Panel Wed Nov 11 13:00–13:45 HTA Regulation: Early Insights and Reimbursement Implications Early lessons from the EU's new joint reviews of how much new drugs help patients, and whether they ease or hinder patient access. Panel Wed Nov 11 10:00–10:45 Most Favoured Nations: A Game-Changer for Biotech Dealmaker? How the US 'most favoured nation' policy, which ties US drug prices to prices paid abroad, is changing drug deals and European launch plans. |
European Commission Brussels, Belgium | |
Executive body of the European Union, proposing legislation and running EU programmes, including health, medicines and research policy. | Panel Tue Nov 10 09:00–09:45 Accelerating Innovation and Market Exclusivity Through Regulatory Incentives How updated EU drug laws and the Biotech Act change how long new medicines are shielded from competing copies, compared with rules elsewhere. Panel Wed Nov 11 09:00–09:45 From NAMs (New Approach Methodologies) Innovation to Regulatory acceptance: Accelerating human-relevant modelling How lab models built on human biology, from organs-on-chips to AI computer models, can speed drug development and win regulators' acceptance. |
Regulatory consultancy advising drug developers on regulatory and commercialization pathways, including gene therapy applications. | Panel Mon Nov 9 14:00–14:45 Community Conversations – Session 1 Attendees join small-group lunch tables on a topic of their choice, from regulatory strategy and global launches to hiring talent and managing partnerships. Business of BiotechRegulatory Strategy Panel Mon Nov 9 15:00–15:45 Community Conversations – Session 2 A second round of the same small-group lunch tables, letting attendees switch to another topic such as regulatory strategy, launches or partnerships. Business of BiotechRegulatory Strategy Panel Tue Nov 10 13:00–13:55 Unlocking APACs Clinical Trials Potential: Navigating Regulatory Pathways, Bridging Strategies and Market Access Across the Region How to run clinical trials and win approval in Japan, Korea, Taiwan and Southeast Asia, and when studies in local patients pay off. |
CSL Behring King of Prussia, PA | ◆Platinum Sponsor |
CSL's biotherapeutics business, making plasma-derived and recombinant therapies for rare and serious diseases. | Panel Mon Nov 9 13:00–14:00 Navigating partnering and business development in a shifting global landscape How funding conditions, treatment trends and geopolitics are shaping partnerships and acquisitions between drug and biotech companies, with real deal examples. Panel Tue Nov 10 14:00–14:45 Harnessing Regulatory Sandboxes to Drive Innovation in Novel Therapeutics & Technologies How regulatory sandboxes, where regulators let new products be tested under adjusted rules, could support new therapies and health technologies in Europe. |
MSD Rahway, NJ | ◆Platinum Sponsor |
Global pharmaceutical company, known as Merck & Co. in the US and Canada, making medicines and vaccines. | Panel Tue Nov 10 13:00–13:45 Aligning with Regulators to Propel Innovation What help and incentives the European Medicines Agency offers developers of new treatments, and how to use them on the road to approval. Panel Wed Nov 11 09:00–09:45 How is the APAC region reshaping global biopharma? How China, Japan, South Korea and other Asia-Pacific countries are moving from making drugs to inventing them, and how Western firms can partner. |
Biogen Cambridge, Massachusetts | |
Develops and markets therapies for neurological and neurodegenerative diseases, including multiple sclerosis and Alzheimer's disease. | Panel Tue Nov 10 16:00–16:45 AI and Innovation in Clinical Trials: Transforming Operations and Accelerating Development How AI can speed clinical trials, from drafting trial plans and finding patients to computer-simulated patients that cut how many real ones are needed. Panel Tue Nov 10 15:00–15:45 Mastering the Shifting Regulatory Landscape: Leveraging the Biotech Act for Innovation and Global Success How the EU Biotech Act shapes cell and gene therapies, and how Europe compares with UK and US programmes for rare and personalised treatments. |
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