On the 10th of October the top industry professionals gathered in Madrid, Spain, for Regulatory Day, an immersive workshop organized by seQure in collaboration with other PM Holding companies and its partners Oracle Health Sciences and Asphalion.
The event, entitled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” brought together the best regulatory, QA, clinical, and pharmacovigilance specialists to discuss how they can collaborate to make the product development journey through post-marketing as efficient as possible both in EMA and FDA regulatory environments.
The Regulatory Day agenda was divided into three sessions, each of them dedicated to a different aspect of product development:
Session #1 Comparison of EMA and FDA Regulatory Landscape in Clinical Trials
- Introduction to FDA and EU Regulatory Activities for Drug Development and Clinical Trials – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
- Integrated Summaries: Strategies for Meeting Regulatory Challenges Faced by Sponsors – Marta Zanus (CROS NT);
- Pre-Marketing Safety Reporting & Signal Detection – Una Kessi (Oracle Health Sciences);
Session #2 Post-Market Regulatory
- Comparison of US vs EU Regulations, Procedures, Requirements, Practical Examples and Submission Format – Lidia Canovas (Asphalion) and Bruce Thompson (Reguliance);
- Surveillance and Safety Obligations after Approval – Una Kessi (Oracle Health Sciences);
- Post-authorisation Studies in the EU: PASS and PAES – Stefania De Santis (seQure);
Session #3 Impact of Technology on Regulatory and Vice Versa
- The (R)evolution of Technology in the Pharmaceutical Sector – Marcos Fernàndez Gómez (Asphalion);
- Digital Transformation in Clinical Trials: eClinical Selection and the Regulatory Impact – Silvia Gabanti (Arithmos);
- How AI and Cloud are Impacting Multivigilance – Michael Braun-Boghos (Oracle Health Sciences);
The final part of Regulatory Day engaged the event guests in the roundtable discussions on where the market is moving and invited them to share their own experience in breaking down the silos between departments in their companies.
- Roundtable #1: Regulatory Challenges in the Industry: EU vs FDA, Brexit, and IDMP
- Roundtable #2: Breaking Down the Silos between Regulatory Affairs, Safety, and Clinical R&D
Breaking Down the Silos: Complexities and Benefits
The information flow between various departments involved in medicinal product development is not always straightforward, especially when it comes to large companies. Due to the structural obstacles and lack of time caused by pressing deadlines regulatory, clinical, and safety professionals might not fully comprehend the work done by other departments.
Collaboration and continuous information exchange between different professionals that work either in EMA or FDA environment favour the acceleration of product development and increase efficiency. Regulatory Day gave participants a sneak peek into the work of their colleagues and challenges they face, inviting them to explore new ways of collaboration.