Effective Strategies For Post-Approval Lifecycle Management And Local Pharmacovigilance

By Vera Dinis, Director, Regulatory Affairs, Regulatory Affairs and Drug Development Solutions, IQVIA; and Ana Pedro Jesuíno, Associate Director, Marketed Product Safety, Data Sciences, Safety and Medical, IQVIA

Though reaching the post-approval phase of your drug’s lifecycle is a momentous achievement, it is not the end of your drug’s journey. As a therapeutic gains access to a much wider population, pharma companies receive greater insight into a drug’s safety profile. They might consider expanding to new markets, registering new forms and dosages, and extending indications. Your team might also adapt manufacturing processes to ensure efficiency and continuous supply, requiring chemistry, manufacturing, and control (CMC) updates that must be supported by data.

If your company is operating across multiple jurisdictions globally, you’ll need an expansive team of experts to manage renewals, CMC variations, and marketing authorization transfers to guarantee effective post-approval management globally. If these tasks seem daunting, consider how partnering with a provider that employs LQPPVs and innovative technology can help. Download the full article to further explore the challenges of post-approval management and learn more about how best to tackle them.