It is important to stay abreast of the latest requirements in pharmacovigilance in order to meet the needs of the regulators. Seema Jaitly writes for Pharma Phorum and cuts
The new legislation has been in place for almost 3 years now and there has been a lot of experience and discussion regarding some of the practicalities of implementation. If
Join Dr. Seema Jaitly on her latest webinar which will look into signal detection in more detail. Great for those who are new to pharmacovigilance or embarking on signal
A large and time consuming part of your role will no doubt include writing detailed reports which face the scrutiny of the regulators. This short webinar being run by Dr Seema
Working in pharmacovigilance, I understand the challenge of all the different reports you’re required to submit, from the DSUR, RMP and PBRER. They all have similar sections
Risk Minimisation isn’t a new concept in pharmacovigilance yet it is rapidly evolving and it can be hard to stay on top of all the latest guidelines and developments.
Dr Seema Jaitly, Managing Director, Essjay Solutions, recently presented at the popular Back to Basics Pharmacovigilance course run by the Drug Safety Research Unit. A large
Valproic acid (VPA), di-n-propylacetic acid, was first synthetized in 1882 by Burton and used as a solvent for pre-clinical testing of lipophilic drugs (1). Its
It doesn’t matter how big or small your pharmaceutical company is, everyone has to go through the inspection process. It’s never going to be a pleasant experience but
Risk minimisation has become a crucial part of pharmacovigilance activities. Manufacturers and regulatory agencies are required to constantly monitor risks and adverse effects