Latest news with #EUClinicalTrialRegulation
Euractiv
01-07-2025
- Business
- Euractiv
Belgian biotech stakeholders urge EU to fast-track innovation and financing reforms
As the European Commission prepares its Biotech Act, Belgium's biotech sector has submitted detailed responses to the Commission's call for evidence, advocating for a bold and comprehensive legislative package. If the EU wants to lead in global biotechnology, the Biotech Act must deliver radical simplification, stronger financial instruments, and smarter regulation, they say. Sharing priorities and concerns, a wide range of Belgian stakeholders, including industry associations, regulators, academic institutions, and patient groups, paint a picture of a country eager to see Europe reclaim its leadership in biotechnology. A turning point for EU biotech Belgium punches above its weight in biotech, home to thriving clusters in Flanders and Wallonia, as well as over 450 innovation-driven biotech entities. But recent trends have raised alarm. Clinical trial authorisations in Belgium dropped by 10% between 2022 and 2023, part of a broader EU decline. 'Over the past five years, 60,000 EU patients missed out on clinical trials,' warned The message from Belgium is clear: without fast, pragmatic reforms, Europe risks falling behind the US and China. 'Regulatory delays, fragmented markets, and lack of capital are costing Europe its biotech edge,' said Biovia, the Flemish health innovation cluster. 'The Biotech Act must turn scientific excellence into global competitiveness.' Streamlining regulation All Belgian contributors emphasise the need to streamline regulatory frameworks, particularly in clinical trials, market access and data governance. called for a reform of the EU Clinical Trial Regulation (CTR) to reduce national divergences, shorten approval timelines, and minimise administrative burdens for modifications during trials. Amgen echoed these concerns, advocating for a centralised EU procedure under EMA oversight, especially for combination products involving medical devices or diagnostics. The Flemish government similarly pushed for harmonised, lean approval procedures aligned across sectors, calling for 'regulatory sandboxes' to support high-risk innovation. The Belgian Federal Agency for Medicines and Health Products (FAMHP) warned of duplicative procedures, inconsistent interpretations between Member States, and a lack of clarity on the regulatory status of advanced therapies. It flagged the need for harmonisation in the handling of genetically modified organisms (GMOs) in clinical trials and import regulations for short-life advanced therapy medicinal products (ATMPs), noting that the current customs procedures are unfit for these innovative medicines. Investing in innovation, not just frameworks Beyond regulation, financing innovation emerged as a central demand. Biovia and VIB both highlighted Europe's chronic funding gap, particularly in growth-stage biotech. 'The EU lags the US by a factor of six to ten in available biotech capital,' Biovia noted, calling for more non-dilutive EU funding, a unified biotech stock exchange, and better incentives for pension funds and long-term investors. VIB proposed a 'EuroTech Stock Exchange' modelled after NASDAQ and urged the Commission to mandate more venture-friendly policies at the European Investment Fund (EIF). 'EIF-backed funds should prioritise excellence, not geographical quotas that distort investments,' it argued. The Flemish government, in turn, advocated for prioritising biotech in the forthcoming European Competitiveness Fund and creating pan-European access to pilot plants and infrastructures, including for SMEs. Digital, data, and AI Belgian stakeholders were aligned in calling for greater digital integration. MSD, and Sanofi stressed the importance of secure, high-quality datasets, interoperable systems, and responsible AI integration. Leveraging the European Health Data Space (EHDS), aligning with the AI Act, and enabling real-world evidence (RWE) use in clinical trials were flagged as top priorities. The FAMHP also called for broadening the focus from AI to include a wider range of digital tools such as modelling, simulation, and 'white-box' computational methods. Meanwhile, Amgen called for a Regulatory Innovation Fund to support digital regulatory sandboxes and keep EMA guidance on biotech manufacturing up to date. Environmental balance A notable concern raised by was the EU's environmental legislation, in particular the Urban Waste Water Treatment Directive (UWWTD). The group urged the Commission to pause its implementation and redesign the directive in line with the 'polluter pays' principle. Currently, only the pharmaceutical and cosmetic industries are expected to foot the bill for micropollutant removal, while industrial chemicals, pesticides, and household products are excluded. 'This undermines both competitiveness and the valorisation of green innovation,' warned. Paediatric oncology In a poignant submission, patient group KickCancer stressed that paediatric cancer research illustrates the untapped promise and systemic failings of the current biotech landscape. The group called for a true single market to support early, multinational paediatric trials, wider access to CAR-T and other ATMPs, and a financing model that combines public and private capital to keep therapies affordable. 'We must build a European model for low-cost, high-impact paediatric cancer treatments,' the group stated. Coordinated ecosystem Belgium's submissions also underscore that biotech policy must move beyond healthcare. The Flemish government and Biovia argued for a full-spectrum approach that includes food, agriculture, industrial biotech, and recycling. Biovia's recent merger of and MEDVIA reflects this shift, positioning itself as a cluster for both human and planetary health. Belgian actors support integrating New Genomic Techniques (NGTs) into climate adaptation policies and promoting sustainable biotech use in agriculture and food. They also called for simplifying Regulation (EC) No 1107/2009 to better accommodate biocontrol products and microbial biostimulants, noting that many promising innovations remain excluded under current EU rules. Belgium's biotech ecosystem speaks with unity on the future of European biotechnology, converging on three pillars: streamline regulation, secure strategic financing, and empower innovation with digital infrastructure. [Edited by Vasiliki Angouridi, Brian Maguire]
Associated Press
30-06-2025
- Business
- Associated Press
The EU Clinical Trial Regulation Virtual Seminar (August 20, 2025): Unravel EU Licensing Pathways for Drugs, Biologics, & Combination Products
DUBLIN--(BUSINESS WIRE)--Jun 30, 2025-- The 'Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registration (August 20, 2025)' has been added to offering. This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips for working with European regulators. The seminar covers the impending changes coming with the EU Parliament's passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing]. This course also covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU level and across the specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. Learning Objectives Attendees will leave the Course clearly understanding the requirements under the current Regulations. In addition, this course has been updated to provide participants with competitive insight into: How the EU and individual countries within Europe Interact This live training Seminar includes the following for each registered attendee: Who Should Attend: Course Agenda: Session 1: EU's New Regulation 535/2014 on Clinical Trials, 2022 (77 slides) Session 2: ICH Q7, API CGMPs and QMS (81 slides) Session 3: Risk Management in EU New Drug Development (53 slides) Session 4: Investigational Medicinal Products (IMPs) (22 slides) Session 5: EU Clinical Trials Application Process (36 slides) Review Q & A For more information about this webinar visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: EUROPE INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 06/30/2025 07:52 AM/DISC: 06/30/2025 07:52 AM
Yahoo
10-06-2025
- Health
- Yahoo
Navigate EU Clinical Trial Regulations with Confidence: Virtual Seminar on EU Clinical Trial Regulation - EU Filings & Registrations
This comprehensive course on EU Clinical Studies covers the EU Clinical Trial Regulation, EU-GCP updates, and new Pharmacovigilance Directive insights. Attendees will learn about EU regulatory frameworks, licensing methods, and effective submission strategies. The seminar includes Q&A, handouts, and certificates. Dublin, June 10, 2025 (GLOBE NEWSWIRE) -- The "Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registration (August 20, 2025)" has been added to offering. This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips for working with European regulators. The seminar covers the impending changes coming with the EU Parliament's passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing]. This course also covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU level and across the specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. Learning Objectives Attendees will leave the Course clearly understanding the requirements under the current Regulations. In addition, this course has been updated to provide participants with competitive insight into: How the EU and individual countries within Europe Interact Which registration procedure to use How regulations affect product development strategies Understanding the concerns/issues of European Regulatory Personnel How to negotiate with the regulators Information necessary for effective submissions Strategies for streamlining the registration application process for faster approval The advantages and disadvantages of various registration procedures How to efficiently initiate trials first patient, first visit How to link the strategy of Country Selection to an ultimate EU registration pathway How to stay compliant What can make the difference in your data passing Regulatory scrutiny Related area-GCP and PV-reporting updates Impending Changes of the EU Clinical Trial Regulation and timing for Implementation This live training Seminar includes the following for each registered attendee: A copy of the presentation slides by download A certificate of participation for attendee training records Q/A Session Free Handouts on EU Clinical Trial Regulation Who Should Attend: Business Management Project Team Members Legal Team Members Clinical Operations Staff Quality Assurance, Monitors, CRAs Regulatory Affairs Investigators & Site Study Staff CROs, Consultants, Insurers Course Agenda: Session 1: EU's New Regulation 535/2014 on Clinical Trials, 2022 (77 slides) Introduction - Foundation of Science-based Clinical Trials Clinical Trial Basics EU Regulation 536/2014, recently implemented Trial subjects' concerns / rights Session 2: ICH Q7, API CGMPs and QMS (81 slides) ICH Q7 API CGMP Additional CGMP considerations Required Records Methods Validation Session 3: Risk Management in EU New Drug Development (53 slides) ICH Q9 Risk Management File - Narrative Hazards List, FTA, D-, P-, U-FME[C]A's Review / Report; Use Session 4: Investigational Medicinal Products (IMPs) (22 slides) EU Medicinal Products Requirements IMPs Session 5: EU Clinical Trials Application Process (36 slides) Application Process AMS, CMS Required documents. Review Q & A For more information about this webinar visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Yahoo
28-05-2025
- Health
- Yahoo
GCP (Good Clinical Practice), Clinical Research and Inspection Training Course: Regulatory Compliance, Recent Legislation, and Technological Advances (ONLINE EVENT: July 7, 2025)
Stay ahead in clinical research with our essential course on EU Clinical Trials Regulation and ICH GCP R3 updates. Benefit from expert insights on regulatory compliance, recent legislation, and technological advances. Earn 6 CPD hours and a completion certificate. Reserve your spot today! Dublin, May 28, 2025 (GLOBE NEWSWIRE) -- The "GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course" training has been added to offering. Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training. This must-attend course provides a review of recent changes to relevant guidance and legislation and will look at how these developments have been implemented and are likely to be implemented. Topics covered will include the EU Clinical Trials Regulation and associated documents and an update on ICH GCP R3 This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors. Who Should Attend: The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance, QA, Audit, CROs, academic trialists and regulatory inspectors. It will also be of interest to those departments who liaise/support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials. Benefits of attending Be updated on ICH GCP R3 Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA considerations Review the requirements of clinical trail essential documentation Identify common audit and inspection findings to help prepare for inspection Understand the EU Clinical Trial Regulation requirements Clarify requirements for data integrity and governance Explore technology advances in clinical trials Certifications: CPD: 6 hours for your records Certificate of completion Key Topics Covered: Brief review of regulatory authority inspection findings EMA, MHRA and FDA findings New ICH GCP E6 R3 draft guideline What is new and likely to impact on running trials Revised principles Data governance Records and reports Key updates, additions and revisions ICH E8 Other ICH updates European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs) ICH E8 Data integrity governance What inspectors look for MHRA integrity guidance compliance ICH GCP R3 Governance requirements EU Clinical Trial Regulation (536/2014) update Key changes and documentation Update since go-live Clinical Trials Information System (CTIS) EU clinical trial authorisation Serious Breaches Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3 TMF structure, content, security, control, maintaining the TMF and storage, e-TMFs, archiving and retention ICH GCP R3 - recommended format for compliance Awareness update from EU and FDA EU EMA Guidance on validation & qualification of computerised systems European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs) Artificial intelligence reflection guidance in lifecycle Stronger enforcement of the GDPR in cross-border cases Real-world data FDA Guidance for industry: considerations for the use of real-world data FDA guidance on enhancing the diversity of clinical trials A risk-based approach to monitoring of clinical investigations Informed consent guidance for IRBs, clinical investigators and sponsors Digitalisation and technology advances and GCP Technology innovations in clinical research Electronic informed consent Apps, medical devices and mobile technologies in clinical trials Artificial intelligence Decentralised clinical trials Conclusion and final Q&A Speakers: Laura Brown Pharmaceutical QA and Training Consultant University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
