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Regulated Seminar for Learning

A seminar titled 'Regulations and Regulatory Affairs' was organised by the MET Institute of Pharmacy (Degree), Mumbai on December 19, 2015. The inauguration of the event was done by lighting of the ceremonial lamp by Dr. U. B. Hadkar, Director, MET IOP, Dr. Abha Doshi, Principal MET IOP (Degree), Ms. Poonam Dhake Kolhe one of the eminent speakers for the seminar, Ms. Bhagyashri Joshi, Ms. Vrushali Keer and Dr. Madhura Vaidya Seminar Co-ordinators. The event began with welcome address by Dr. Hadkar, who expressed gratitude to the speakers for accepting the invitation. He appreciated the efforts taken by Dr. Abha Doshi to make this seminar a huge success.

Scientific Session I began with a talk on 'Intellectual Property Rights' by Ms. Poonam Dhake Kolhe (Patent & Trademark Attorney), Partner - IN10GIBLE INNOVATIONS LLP. Ms. Poonam threw light on different Intellectual Properties and case studies. She also brought out importance, significance and commercial values of intellectual property to the notice of audience.

Dr. Alka Mehta in her talk titled 'Applications and Case Studies related to Patents' explained case studies for different drugs and formulations in a very lucid manner. The next talk was on 'Role of Central and State Government in Drug Quality Maintenance' by Mr. Dhananjay Sable, Drug Inspector, CDSCO. He explained hierarchy in posts in central and state government and their roles in quality maintenance for drugs and cosmetics. He threw light on role of CDSCO (Central Drugs Standard Control Organisation) and also how to enter the team at government level for maintenance of quality of drugs and cosmetics.

Poster competition based on case studies related to Drugs and Cosmetics Act and IPR was held on the day. Third year and final year students of MET IOP (Degree) and few other eminent pharmacy colleges participated actively. Poster presentation was judged by Ms. Poonam Dhake, Mr. Nikhil Chavan, Executive, Drug Regulatory Affairs, Lupin Pharmaceutical Ltd. And Mr. Mohit Patwardhan, Executive - Patent Attorney Intellectual Property Cell Litigations, Sun Pharma Industries Ltd.

Session II started with a talk on 'Landscape for Regulatory Aspects of Excipients' by Dr. Vaishali Tawde, General Manager - Technical Service, Pharma Ingredients and Services. She explained regulatory guidelines for Diluent/Vehicle/Fillers/Binders/bulk agent/lubricants for drug formulation, so that they enable the drug to give desired pharmacological action. The last speaker Mr. Vikas Biyani, Assistant Commissioner, FDA, Maharashtra State in his presentation titled 'Role of FDA in Pharmaceutical Product Quality Management' explained the topic with case studies from his own rich experience.

The seminar was concluded with Dr. Abha Doshi proposing a vote of thanks on behalf of MET Institute of Pharmacy (Degree).


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