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Sponsored: Future Trends on European Medicines Regulations
FREE SPONSORED WEBINAR - Future Trends on European Medicines Regulations - UPDATED FOR 2023
11 July 2023
15:00 - 16.00 BST
The European Commission announced on 25 November 2020 the adoption of the new Pharmaceutical Strategy for Europe. It is an approach intended to ensure strong, fair competitivity and green industry, fostering patient access to innovative and affordable medicines. It will ensure an autonomous and robust supply chain and a stronger EU voice at the global level by promoting a high level of quality, efficacy and safety standards.
The Pharmaceutical Strategy is based on 4 main pillars:
- Accessibility and affordability of medicines for patients and addressing unmet medical neds
- Competitiveness, innovation and sustainability
- Diversified and secure supply chain
- Ensuring a strong EU voice in the world
Also, as part of the Pharmaceutical Strategy for Europe, the Orphan Regulation 141/2000 and the Paediatric Regulation 1901/2006 are under revision and the European Commission adoption is expected by Q4 2022.
Veristat will examine and discuss the new medicinal products Regulatory framework in Europe. This webinar will include a Q&A session with our experts.
They will share their experience of knowledge with regards to the following aspects:
Unmet medical need
Accessibility and affordability
Competitive and innovative European pharma industry
Enhancing resilience – diversified and secure supply chains, environmental sustainability.
Ensure EU voice globally
• Delegates from the regulatory affairs industry who wish to obtain a better insight into the new regulatory framework in Europe.
• Regulatory Professionals who wish to gain a comprehensive understanding of the subject.
• Less experienced regulatory affairs professionals
Xavier Luria, MD,
Vice President, Regulatory Affairs Europe, Veristat
Xavier Luria, MD, is responsible for providing strategic and implementation counsel across the spectrum of global regulatory and pharmacovigilance services for drugs, IVDs, and medical devices. Levering his deep expertise, Dr. Luria drives productive communication with health authorities and associated meetings and submissions, along with overseeing the development of impeccable project regulatory documentation and safety reporting.
Dr. Luria has nearly a decade of experience offering regulatory consulting within industry, 7 years of experience working as Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA) and spent the prior 18 years in the pharmaceutical industry.
In addition to Dr. Luria’s specialty in internal medicine, and pharmaceutical medicine and biostatistics (University Autonomous Barcelona), he has developed expertise in several specific therapeutic areas, carried out postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston), and he is a recognized expert on regulatory systems and benefit-risk assessment (modelling, development and methodologies).
Associate Director, European Regulatory Affairs, Veristat
Michael has 15 years of experience within Regulatory affairs: in CTA (early-stage development to late-phase projects), Scientific advice, PIPs, and special procedures (i.e., SME status and Orphan designation. ATMP Classification & Certification) within the EU, initial MAA, and post-approval experience (variations), Regulatory strategy, Regulatory advice on Protocol, IMPD and IB preparation for submission to Ethical and Competent Authorities. Scientific dossier writing (e.g., IMPD, documents specific to Module 1, 2, and 3 and assisting in review and compilation of Module 4 & 5 of the eCTD. Managed and provided oversight for regulatory submissions to UK (MHRA), US (CBER) Singapore (HSA). Regulatory Lead for regulatory roadmap, strategy, and submissions.
Michael earned a bachelor’s Honours degree in Pharmaceutical Sciences from the University of Greenwich and is an MTOPRA member.
Associate Manager, European Regulatory Affairs, Veristat
Paula has managed and provided oversight of preparedness and submission of Marketing Authorisation Applications with the EMA, Orphan Drug Designations, Scientific Advice, Paediatric Investigational Plans, and Small-Medium Sized Enterprises within the EU. Regulatory Lead for regulatory strategic analysis and roadmaps for the development of medicinal products.
Paula earned a bachelor’s degree in Biomedical Science from the University of Lleida, a master’s degree of Biomedicine specialized in Basic and Translational Research in Cancer of the University of Barcelona and a Postgraduate Program in Biotech and Pharmaceutical Industry of Institut Químic de Sarrià.
This webinar is sponsored by Veristat.
Whilst TOPRA is running this webinar for Veristat, this is not an endorsement of Veristat, Veristat's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
11/07/2023 15:00 - 16:00
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