Express Pharma

High Potent Drugs-2013 debates regulatory complexities

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Sachin JagdaleMumbai

In the pharmaceutical industry potency is the measure of drug activity. Such drugs generate large response at lower concentrations. As these drugs are sensitive in nature, technology used in their manufacture become crucial for the manufacturers. Recently concluded, High Potent Drugs-2013 conference in Mumbai brought together international and domestic experts who discussed high potent drugs related R&D and manufacturing issues.

Speakers talked about things that may decide the future direction of domestic and global high potent drugs manufacturing industry. As regulations have always remained one of the most challenging aspects for the pharma industry, discussions were focussed on overcoming the regulatory complexities involved in high potent drugs and understanding specific documentation requirements to ensure compliance with global regulatory standards. Audiences were updated on the latest cGMP requirements for potent drugs to ensure compliance with the global standards. Technology predominantly remained the focus during the conference.

Speaking about the event, Vishal Sharma, Co-Founder and Director, Vienni Training and Consulting LLP said, “It is a need of the hour for Indian drug manufacturers to come together on a neutral platform(s) and share knowledge. India has already emerged as a global player in pharmaceutical industry. In order to sustain this momentum it is important for us to develop mechanisms to come together and discuss technical issues threadbare.”

The strategic meet covered a wide gamut of topics that concern advances in high potent drug development, manufacturing and facility design to ensure swift market introduction of cost-effective and consistent quality high potent drugs. A workshop was also held on facility design and engineering control requirements for high potent drugs.

At High Potent Drugs-2013, senior industry experts such as Justin Mason from Safebridge, Dean Calhoun from Affygility Solutions, Rino Coladangelo from Rephine, Dr Bhaswath Chakraborty from Cadila Pharmaceuticals and Jatin Gajjar from Famy Care, shared valuable insights on significant approaches in the high potent drug domain. The participation of presidents, directors, Heads of R&D, manufacturing, formulations and containment equipment from across the globe made the event a highly successful one.

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