Excerpts from PharmaAQ Expert Forum – “OOS/OOT Investigations – Overcoming Challenges” held on October 22, 2021, online. In this form, several experts addressed several issues raised by the industry participants. Some of those questions have been given below for the reference of other colleagues. In case you are looking for answers to any of these, please do… continue reading »
Article by Sanjay Bajaj, Ph.D. Discovery of a new drug molecule is estimated to take over 2.5 billion and over 10 years of extensive research. It is not that the new molecules are hardly discovered but a large number of molecules qualifying as drugs fail during Phase II or Phase III clinical trials mainly because… continue reading »
Article by Dr Sanjay Bajaj
Success and failure are usually treated as complementary to each other. A lot has been said failure too and one of the sayings which sounds very practical and positive is by Thomas Edison, America’s greatest inventor and holder of over 1000 patents. He said, “I haven’t failed — I’ve just found 10,000 ways that won’t work”.
We do understand that in research, we have to do lot of experimentation, and lot of those experiments do not work.
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.
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.