Seamless COVID-19 Vaccine Development & Clinical Trials – Regulatory Recommendations & Relaxations – A Regulatory Update by Dr Sanjay Bajaj
Regulatory agencies United States Food and Drug Administration (US FDA), European Medicines Agency (EMA) and World Health Organization (WHO) have taken steps to facilitate the timely development of safe and effective vaccine and have issued guidance for the industry with respect to the development of COVID-19 vaccine, and conduct of its clinical trials.
Category: Regulatory Update
EU Pharmacovigilance Expectations
EU Regulatory Q&A Updates on Pharmacovigilance Activities for MAH’s during COVID-19 Pandemic – A regulatory Update by Dr Sanjay Bajaj
COVID-19 pandemic has been specifically tough for the pharmaceutical industry across the globe. Providing safe and sufficient quality medicine for the sick as well as for the prevention of diseases has been a great challenge in the times of lockdown while struggling with a lack of workforce and pandemic situations.
