Drug Information Association (DIA) is organizing the 5th Regulatory conference: Evolving Global Regulatory Environment on April 13-14 at Hotel ITC Grand Maratha, Mumbai.
This conference will bring together regulatory professionals, academia and regulators to discuss various aspects of evolving global regulatory landscape particularly on: new changes in EU regulatory environment e.g. new variation guideline and implementation, paediatric regulation, emerging and evolving biosimilar regulation in India, EU, US, South Korea, Brazil and Russia, focus around complex generics and evolving understanding, quality and compliance in manufacturing and clinical trials, special focus on regulatory affairs’ profession and career with Q&A with leading regulatory professionals.
Mahesh Zagade, commissioner of Food & Drugs Administration, Maharashtra State and programme advisor will be present along with the programme committee: Dr Albinus D’Sa, deputy director, US FDA, India, P R Uttarwar, joint commissioner (HQ) & Controlling Authority, Food & Drug Administration Maharashtra, Dr H G Koshia, commissioner, FDCA, Gujarat, Dr R Ramkrishna, Deputy Drugs Controller India, CDSCO, West Zone, Mumbai, Omprakash Sadhwani, joint commissioner (Law), Food & Drug Administration Maharashtra, Janis Bernat, senior manager, Biotherapeutics & Innovation, IFPMA, Dr Shoibal Mukherjee, vice president, Medical Quintiles, Dr R S Gaud, dean, Pharma Sciences, NMIIMS, Dr Aberto Grignolo, PhD, Corporate Vice President, Global Strategy, PAREXEL Consulting, Dr Vinay Nayak, President Technical, Alembic, Dr Adnan Mahmood, MD, Clinical Research Physician, Janssen Pharmaceutical Companies, J & J, Paul Ellis, director, External Advocacy, GlaxoSmithKline, UK.
International speakers are also invited for the conference which includes: Lawrence Liberti, executive director, Centre for Innovation in Regulatory Science (CIRS), UK, Michael Rozycki, vice president, Regulatory Affairs, Asia Pacific, Allergan China, Clemens Laumeier, director - Emerging Markets, EXTEDO GmbH, Raj Long, senior regulatory consultant, Janis Bernat, senior manager, Biotherapeutics & Innovation, IFPMA.
DIA is the premier professional member association in the world addressing solutions to issues and challenges across the entire drug development industry. Its professional development opportunities, timely information resources and global network of thought leaders allow you to take control of your career.