WEBINAR: Thursday, October 12, 2017 Your organization spends a considerable amount of effort and resources on planning, authoring, and distributing aggregate reports. Given the inherent complexities, it is easy to see how companies can lose oversight or create inefficiencies in their aggregate report process. Without a good handle on these operational complexities,[…]
Patients and regulatory authorities are asking for more patient/sponsor communication over the drug development cycle. At the same time, many sponsors seek to better understand the value of different investments to meet this demand. They are converting patient insights into journey maps and case studies that are producing a variety of new technologies and services[…]
Anxious that your upcoming Health Authority Inspection will bring more CAPAs? Your organization spends a considerable amount of effort and resources on processing pharmacovigilance cases — but you’re still not sure your upcoming inspection will leave you without an additional CAPA headache. Ever wonder what it would be like to go into an inspection confident[…]
Patient centricity ideas are everywhere today. But, too often it is not seen by patients in a clinical trial. It seems like – the patient is at the center but the patients’ point of view is not. Patient Centricity – Sponsors vs. Patients Today, patients are asking for more input with sponsors throughout the drug development cycle. And regulatory[…]
With the largest change in regulations in the European Union becoming fully effective in July 2015, it is not an understatement to say the Pharmacovigilance environment is changing at an unprecedented pace. These new regulations work to strengthen transparency and communication and enhance drug safety. However, transitioning to comply with these regulations can be challenging.[…]