We are delighted to present the outcomes of the DIA Europe 2024 Pre-Conference Workshop on "Reliance for Post-Approval Changes: How do we move from Exceptional to Routine Use?" and the DIA Global Forum Article on "Making Global Reliance a Reality for Post-Approval Changes of Medicines and Vaccines".
As the regulatory landscape evolves, the need for global collaboration has never been more critical. This workshop brought together global regulators and industry leaders to discuss how reliance models can be expanded to streamline post-approval changes (PACs) across markets. The outcomes highlight key steps toward making reliance for PAC a routine practice, reducing delays, and ensuring timely access to medicines and vaccines worldwide.
◾ Download the outcomes: https://bit.ly/4cKzpzm.
◾ Read the Global Forum article: https://bit.ly/3X8Nzok.
As we look ahead, we invite you to join us at the DIA Europe 2025 to continue these critical discussions. Let’s work together to foster collaboration, drive innovation, and create a sustainable future for global healthcare. Register by 14 November to benefit from the early bird rate.
◾ Registration link: https://bit.ly/4aN1NA1.
Chimwemwe Chamdimba, Biljana Tubić, Elkiana Rama, Nélio Cézar De Aquino, Jiaqi Lu, Tao Wang, Xiangyu Wang, Sabina Uzeirbegovic, Hamada Gamal, Martin Harvey Allchurch, Reem Al-Naimat, Ahmed Hussein Babiker, Bandar Alhammad, Marko Eric, Mladen Bogdanovic, F. Handan Öztunca, Musa Durak, Marie Valentin, Samvel Azatyan, Gugu N Mahlangu, Alison Bond, Lucia D'Apote, Mark Pellett, Priti Shah, Michael Cunha, Vera Lucie Wardhana, Hugo Ta, Michelle Czajkowski, Andrew Deavin, Dave Rush, Sérgio Cavalheiro Filho, Ginny Beakes-Read, Greg Jordinson, Chloé Garay, Sonia Cappellini, isabelle colmagne-poulard, Wan Li Liao, PhD, Angelika Joos, Mic McGoldrick, Inas Hujeiri Chehimi, Jacob Larsen, Aine Kane, Anjana Patel, Yameng (Melly) Lin, Susanne A., Corinne CHABASSOL, Lyne Le Palaire, Anna Czwarno, Magda Bujar, Tamei Elliott, Sara Torgal
#DIAEurope2025 #LifeSciences #Sustainability #Reliance #Collaboration
Senior Project Manager, Regulatory Affairs Strategist, and Innovations Leader I GERMAN citizen
1moDoes it apply for platforms under development too, e.g., in preparation for FIH?