Presenting on the above topic is Dr Shivraj Dasari, Vice President, Q.M.R.A, Inno Bioventures Sdn. Bhd., Malaysia. He will be speaking at Pharma & Biotech Supply Chain Asia 2012, part of a series of conferences at the 5th Annual BioPharma Asia Convention 2012, held on 19-22 March at Marina Bay Sands, Singapore.
Dr Shivraj Dasari is Vice President, Quality Management & Regulatory Affairs, at InnoBio Ventures Sdn.Bhd, Malaysia. He is currently responsible for developing and implementing Quality Management systems meeting USFDA, EMEA, and Malaysian FDA (NPCB) standards. He is also responsible for implementation of policies & systems for cGMP; development & review of SOPs; audits, compilation of regulatory dossiers of INDs for marketing authorizations. Dr. Shivraj is a PhD in Microbiology, from Osmania University, India. He possesses the following professional affiliations: ISPE, Indian Chapter; PDA, USA; Approved Chemist/ Microbiologist (Directorate of DCGI, A.P., India); and a Qualified Lead Assessor, empanelled with DST,Govt. of India, ISO 9001:2000, NABL 17025 & 15189 Quality Management Systems. Having joined InnoBio Ventures after gaining experience in the biopharma & stem cell therapy industry for more than 20 years, Dr Shivraj has accumulated a vast experience in compilation of regulatory dossiers for registration and approvals of manufacturing facilities for vaccines and other r-DNA based biopharmaceutical products in over 35 countries.
His educational background and knowledge of regulatory requirements for conduct of Preclinical animal toxicology studies and ICH CTD have aided in his preparation of IND dossiers for marketing authorizations filed in several countries. Previously, he worked at Stempeutics Pvt.Ltd., Manipal Hospitals group, Bangalore, India where he was responsible for developing and implementing Quality Management Systems complying with cGTP- 21cfr 1271. He was also an Adjunct Professor, at Department of Regenerative Medicine, Manipal Institute of Regenerative Medicine, Bangalore. He also previously worked at Dr Reddy’s Labs where he was responsible for implementation of Quality policies & Quality Management System as per WHO GMP (Geneva), US FDA, & EU.
Dr Dasari will be addressing the issues below:
1. QA role in Supply chain management;
2. Geographical conditions of the Technical space and Regional requirements;
3. Regulatory requirements for maintaining Quality
Dr Dasari will also be participating in the following panel discussion:
Panel Discussion: Overcoming business risks and uncertainties in a dynamic global supply chain network