IPA Mah holds lecture on pharma management

EPP News Bureau - Mumbai

Ram Banarse, president, IPA-MSB presenting memento to Dr Ajaz Hussain

The Maharashtra State Branch of the Indian Pharmaceutical Association (IPA) recently organised a lecture on ‘‘Pharmaceutical Uncertainty Manag-ement: Achieving the goal of time to market and productivity improvement.’’

Dr Ajaz Hussain, deputy director, CDER USA FDA while delivering the lecture dwelt on the need to be flexible to have competitive edge. Biotechnology is the answer for diseases of tomorrow and quality is the key word in this industry, he said.

A press release said, it has been the endeavours of regulators the world over to strive towards development of safe and potent molecules which can be vouched for its efficacy.

The supply chain does not end with procurement of materials and supply of finished goods. Value addition and constant upgradation of product profile is the need of the hour and therein lies the competency of the business unit, the release added.

Dr Hussain also elaborated the limitations of the current regulatory system adopted by the USFDA and highlighted the importance of Process Analytical Technology (PAT) and the risk based approach.

He also presented the issues related to biogenerics or follow-on biotechnology products.