The CGT/ATMP Landscape & Challenges in Safety Data Collection

At PrimeVigilance, we understand that Advanced Therapy Medicinal Products (ATMPs) / Cell & Gene Therapies (CGTs) are poised to define the next generation of medical care. To enable specialization, PrimeVigilance has dedicated a Business Unit to this area, which supports clients facing the high regulatory scrutiny and challenges often associated with requests for the conduct of long-term follow-up studies, extending decades into the future. ATMPs/CGTs are synonymous with rare diseases, meaning sponsors and investigators often personally know the patients being treated, bringing a new dynamic to these engagements.

What does all this mean in practice when considering entering the space as either a Biotech or commercial organization? How can you be sure you have a PV partner you can trust to navigate the complexities associated with global regulations and the challenges in ensuring efficacy and effective safety data collection? Join us for our upcoming webinar to delve deeper into these topics and gain valuable insights into the world of ATMPs and the crucial role of pharmacovigilance.