Time
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
Overview
Bringing a new pharmaceutical product to the European market requires a deep understanding of complex regulatory frameworks, procedures, and compliance standards.
This webinar provides a comprehensive overview of the key steps and requirements for successful registration, making it highly relevant for professionals involved in regulatory affairs, pharmacovigilance, quality, and product development. Whether you are planning a centralized procedure or navigating national submissions, this session will clarify essential concepts and offer practical insights.
By attending this webinar, participants will be able to:
– Understand the main EU marketing authorization procedures (centralized, DCP, MRP, national)
– Identify key components of the Common Technical Document (CTD)
– Recognize the pharmacovigilance system requirements for product registration
– Describe the regulatory expectations for CMC, non-clinical, and clinical data
– Plan the timeline and resources needed for successful EU registration
– Understand the post-marketing obligations and variation procedures
Benefits of Attending:
Participants will gain actionable knowledge to support strategic planning, dossier preparation, and cross-functional coordination during the EU product registration process. The session will help reduce regulatory risks, improve time-to-market, and ensure compliance with EMA and national authority expectations. Attendees will also receive practical guidance that can be applied immediately in current or upcoming registration projects.
At this must-attend webinar, don’t miss out on this opportunity to learn expert strategies for EU market access, product registration, and pharmacovigilance.
Speakers
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Mercedina del PapaChief Regulatory Officer at PQE GroupMercedina is a pharmacist with a master’s degree in “Pharmacovigilance and Regulatory Affairs” and a second master’s in “Management & Marketing in Pharmaceutical Industry” with more than 17 years of experience in Regulatory Affairs, Pharmacovigilance, Advertising, and Scientific Services. She has built strong expertise in both strategic and scientific advisory roles, particularly in clinical development. Her background covers a wide range of therapeutic areas, covering both generic and original medicinal products. Her professional experience spans a wide range of therapeutic areas of medicinal products (from generics to originals), covering both safety and regulatory aspects of medicinal product life cycle; she has a proven track record of collaborating effectively with healthcare professionals and regulatory bodies to achieve common goals.
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Daniela RotaOperations Manager - GVP Compliance & Senior Associate PartnerAfter earning a degree in Medical Biotechnology followed by a Master’s in Bioinformatics from the University of Milano-Bicocca, she pursued a PhD in Biomedical Technologies at the LITA-Segrate Scientific and Educational Center.
Her career in pharmacovigilance began in 2008 at ADIENNE, a biopharmaceutical company specializing in orphan drugs. During her time there, she gained hands-on experience across the full spectrum of pharmacovigilance activities, eventually taking on various roles, including that of EU Qualified Person for Pharmacovigilance (EU QPPV).
The solid expertise she developed in pharmacovigilance and quality assurance within the pharmaceutical industry led her to transition into consulting. In 2016, she joined the pharmacovigilance unit at PQE (Pharma Quality Europe), an international consulting firm providing specialized services to pharmaceutical and medical device companies. She initially served as a PV auditor and QA specialist, before being appointed Head of the Pharmacovigilance Business Unit.
Today, she leads an international team of PV professionals and oversees PQE’s global pharmacovigilance and quality assurance services.
Partner
Pharma Quality Europe Srl
Website
https://www2.pqegroup.com/With over 2,000 employees, PQE Group is a woman-owned leading Life Science consulting firm, providing full GxP Quality Support in every phase of the products' life cycle. With a focus on innovation, efficiency, and sustainability and with a global presence through its 45+ offices located around the world, PQE Group continues to set industry benchmarks and drive positive change in the Life Science sector.
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Who Should Attend:
Professionals in:
Pharma, Biotech, Medical Device, Veterinary companies, and CROsPositions:
• Regulatory Affairs
• Pharmacovigilance
• Quality Assurance / Quality Management
• CMC (Chemistry, Manufacturing and Controls)
• Medical Affairs
• Research & Development (R&D)
• Marketing / Market Access
• Legal & Compliance
• Business Development / Licensing - Skill Level: Intermediate
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Topics:
- Overview of EU Marketing Authorization Procedures (centralized, decentralized, mutual recognition, national)
- Key dossier requirements and pharmacovigilance system expectations (CTD structure, QPPV, PSMF, RMP)
- Planning registration timelines, post-marketing obligations, and cross-functional collaboration
- Q&A session
- Open discussion
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Special event information:
All participants will get a complimentary certificate of attendance courtesy of the webinar's partner - PQE.
Time
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
Speakers
-
Mercedina del PapaChief Regulatory Officer at PQE Group
Mercedina is a pharmacist with a master’s degree in “Pharmacovigilance and Regulatory Affairs” and a second master’s in “Management & Marketing in Pharmaceutical Industry” with more than 17 years of experience in Regulatory Affairs, Pharmacovigilance, Advertising, and Scientific Services. She has built strong expertise in both strategic and scientific advisory roles, particularly in clinical development. Her background covers a wide range of therapeutic areas, covering both generic and original medicinal products. Her professional experience spans a wide range of therapeutic areas of medicinal products (from generics to originals), covering both safety and regulatory aspects of medicinal product life cycle; she has a proven track record of collaborating effectively with healthcare professionals and regulatory bodies to achieve common goals.
-
Daniela RotaOperations Manager - GVP Compliance & Senior Associate Partner
After earning a degree in Medical Biotechnology followed by a Master’s in Bioinformatics from the University of Milano-Bicocca, she pursued a PhD in Biomedical Technologies at the LITA-Segrate Scientific and Educational Center.
Her career in pharmacovigilance began in 2008 at ADIENNE, a biopharmaceutical company specializing in orphan drugs. During her time there, she gained hands-on experience across the full spectrum of pharmacovigilance activities, eventually taking on various roles, including that of EU Qualified Person for Pharmacovigilance (EU QPPV).
The solid expertise she developed in pharmacovigilance and quality assurance within the pharmaceutical industry led her to transition into consulting. In 2016, she joined the pharmacovigilance unit at PQE (Pharma Quality Europe), an international consulting firm providing specialized services to pharmaceutical and medical device companies. She initially served as a PV auditor and QA specialist, before being appointed Head of the Pharmacovigilance Business Unit.
Today, she leads an international team of PV professionals and oversees PQE’s global pharmacovigilance and quality assurance services.
Partner
Pharma Quality Europe Srl
Website
https://www2.pqegroup.com/With over 2,000 employees, PQE Group is a woman-owned leading Life Science consulting firm, providing full GxP Quality Support in every phase of the products' life cycle. With a focus on innovation, efficiency, and sustainability and with a global presence through its 45+ offices located around the world, PQE Group continues to set industry benchmarks and drive positive change in the Life Science sector.
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