Pharmacovigilance Webinar: Avoid CAPAs and Enhance Health Authority Inspection Readiness

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[…]

Webinar: Practical Approaches to the EU Pharmacovigilance System Master File (PSMF)

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.[…]

Case Report Form Training

Case Report Forms.  In the world of clinical research, these forms are the basis for marketing approval.  Well-designed, they can foster faster, better and more accurate completion.  But be it paper-based or electronic, training users to use them can be a challenge. Even if trained correctly, there are often a series of delays from after[…]