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SCOPE US 2025
SCOPE US 202516th Annual SCOPE Summit for Clinical Ops Executives
Veristat is excited to announce our participation in...
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Veristat and TOPRA hosted a new updated content webinar on the topic: Future Trends on European Regulations on Medicines
What You Will Learn
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 needs
- 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 Pediatric Regulation 1901/2006 are under revision and the European Commission adoption is expected by Q4 2022.
Veristat Regulatory experts will examine and discuss the new medicinal products Regulatory framework in Europe. This webinar will include a Q&A session with our experts.
Our experts will share their experience of knowledge with regards to the following aspects:
- Unmet medical needs
- Accessibility and affordability
- Competitive and innovative European pharma industry
- Enhancing resilience – diversified and secure supply chains, environmental sustainability.
- Ensure EU voice globally
Meet the Speakers
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 the 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 (modeling, development, and methodologies).
Michael Paul
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.
Paula Meler
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.
Learn More
- View our Expedited Pathways Infographic
- Learn more about our Regulatory Consulting Expertise
- Download our IND Infographic