Drug Information Association (DIA) India is now all set for the 6th regulatory conference to be held from May 23 to 24 2013 at the Courtyard Mariott Ahmedabad. The two day event would have deliberations on regulatory issues on the first day followed by exhibits of tabletop displays by the pharma and the allied industry to tap the marketing opportunities.
The event will have the presence of Dr G N Singh, Drug Controller General of India (DCGI) as the guest of honour. The key note address would be delivered by Rajiv Gulati, president, global pharmacueticals business, Ranbaxy Laboratories Limited, US.
The programme committee comprises Hemant Koshia, commissioner, Food and Drugs Control Administration, Gujarat, K Anand, president, global quality and regulatory affairs, Zydus Cadila, India and Rajeev Mathur, head, global regulatory affairs, Ranbaxy Labs.
This conference brings industry experts, senior management professionals, academicians and regulators together. While the achievements in reaching global standards in India have been significant, a lot more needs to be done to stay competitive in the world market due to ever-evolving stringency on regulatory enforcements. This conference will help understand the challenges and how to be prepared to face up to the complexities of regulatory requirements, said DIA.
The event would be relevant to officials from the regulatory affairs representing not just government but the industry. It would highlight clinical R&D, pharmacovigilance, clinical trial and project management, quality, manufacturing & controls, QA, QC and product development.
The learning objective is that it would help participants facilitate discussions on common issues in the regulatory and technical areas in India. All attendees will receive a DIA certificate at the conclusion of the event.
Session 1 is on dosage forms where Subramanian Iyer, associate vice president, Mylan Laboratories Limited, India would address on GbD approaches in drug development. MS Mahadevan, president & chief executive officer, Biozeen, would highlight on the regulatory aspects of Aseptic Technologies
The second session on biologicals will highlight the regulatory pathways in biosimilars by Sanjeev Kumar, senior vice president, Zydus Cadila. It will also cover the role of biological assessment in drug discovery by Ivy Louis Founder, Vienni Training & Consulting LLP, India.
The third session on medical devices will have Daniel Shoukier, global regulatory affairs director, Biosensors International, Germany speak on the regulatory aspects of devices & drug combination products. Sumati Randeo, associate director, regulatory strategy & policy advocacy, Asia Pacific, Abbott Labs, India will address on the regulatory paradigm for medical devices clinical trials in India.
The concluding session is on skill development where Ivy Louis will provide an overview on the role of training of enhancement of human skills, Yusuf Jaliwala, Principal, Indore Institute of Pharmacy will speak on the interface of academia in shaping young students to future industry challenges and Alok Sonig, India head, senior vice president, global generics, Dr Reddy's Labs, Hyderabad, will speak on business development in pharma industry: opportunities and challenges.