Join us for an insightful workshop delving into the intricacies of the ongoing revisions to the EU Pharmaceutical Legislation. This is the largest reform in over 20 years, shaping the future of the regulatory landscape in Europe. Our workshop, 'Navigating the Future: Understanding and Adapting to the New EU Pharmaceutical Legislation,' is designed to provide pharmaceutical professionals, regulatory experts, and industry stakeholders with comprehensive insights into the proposed legislative changes. Explore the key provisions, regulatory updates, and compliance requirements introduced by the new legislative framework, gaining a deep understanding of their implications on drug development, market protection, EMA simplified structure and organisation and other new or strengthened regulatory requirements on environmental risk assessment and medicinal supply. This workshop aims to equip participants with the knowledge and tools necessary to adapt to the evolving regulatory landscape, fostering successful product development and market entry within the EU. Don't miss this opportunity to stay ahead of the curve and position your organization for success in the dynamic pharmaceutical market.
Registration Fees & Deadlines
1 November 2023 – 27 January 2024: Member €975 | Nonmember €1,155
28 January 2024 – 27 February 2024: Member €1,155 | Nonmember €1,350
Learning Objectives
- Understand the legislative Drafting process & current status
- Understand the Key changes introduced, and their implications to drug developers and manufacturers
Audience Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend?
Regulatory Affairs Professionals
Agenda
- Legislative Reform Process
- Key Changes Introduced
- Orphan Drug designation
- Paediatrics
- Changes in Market Exclusivity
- EMA Simplification
- Other Regulatory changes eg Abolishment of Renewals & Sunset Clause, medicine shortage Prevention Plans, Regulatory Sandbox
Speakers
Charlie Mortazavi, Pharm.D.
Associate Director, Global Regulatory Affairs, Sanofi
Charlie Mortazavi is an Associate Director in Global Regulatory Affairs at Alexion with more than 12 years combined experience in drug development and regulatory strategy covering multiple therapeutic areas, among which oncology, anti-infective, and ultra-rare metabolic diseases. His experience covers successfully MA filing experience and securing worldwide approvals for multiple investigational, new and supplemental drug applications.
Prior to joining Alexion Charlie held regulatory positions at Sanofi, Pfizer, IPSEN and GSK. Charlie earned his Doctor of Pharmacy degree from the University Catholic of Louvain in Belgium with a specialized master degree in drug regulation from the School of Pharmacy of Strasbourg in France.
Kate Stockman, phD, FTOPRA
Vice President Regulatory Affairs Europe, Africa & Middle East, Johnson & Johnson Consumer Healthcare
Accommodations & Travel Information
Hilton Rotterdam
Weena 10
Rotterdam, 3012 CM
Netherlands
Check-in Date: 28 February 2024 | Check-out Date: 1 March 2024
Booking Information: RAPS has negotiated a rate of €179 including VAT. Please note there is an additional 6.5% city tax per room per night.
Reserve your room here
Book by 26 January for best availability.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All requests for cancellations must be received in writing at support@raps.org by 11:59 pm Eastern Time on 30 January 2024. Requests received by 1 January will be assessed a 10% fee. Requests received between 2 January and 30 January will be assessed a 50% fee. Cancellation requests received after 30 January will be non-refundable, except in cases of documented medical emergencies.
Refunds will not be issued for no-shows.
Proof of Attendance
A certificate of attendance will be sent after the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org