Indian pharma industry enjoys a position of prominence and power in the global pharmaceuticals industry. It is amongst the global leaders in providing quality generics to the world. Indian generic drugs market has posted an impressive growth pattern over the last few years and continues to do so. The Indian pharmaceutical sector is estimated to account for 3.1 - 3.6 per cent of the global pharmaceutical industry in value and 10 per cent in volume. India continues to be a major player accounting for 20 per cent of global exports in generics and stood at a staggering US$ 16.84 billion in 2016-17. Estimates expect it to reach US$ 20 billion by 2020. With advantages such as Pharma Vision 2020 aimed at making India a global leader in end-to-end drug manufacturing, reduced approval time for new facilities to boost investments and 100 per cent FDI allowed under automatic route, the sector is poised for stupendous growth in years to come.
To supplement this growth, companies need to mitigate any challenges and risks that may accompany such monumental growth. It is of grave importance to pharma companies that quality, regulatory and compliance concerns are overcome to avoid any roadblocks along the way. Government bodies and other stakeholders will have to play a great role in establishing a strong regulatory set-up as well as a speedy redressal for related issues. Companies will have to step up their quality and manufacturing compliances in line with the global guidelines.
To bridge the gap between external requirements and internal obligations, CPhI India brings to you the 7th Annual Global Pharma Regulatory Summit 2018 scheduled on 30th May, 31st May and 1st June in Mumbai focusing on the clarification and interpretation of the most critical regulatory guidelines established by CSDCO, FDA, EMA, PMDA, Africa and CFDA.
Powered by unparalleled content, the conference promises to see a gathering of renowned international and Indian experts, who have done path-breaking work in their area of work.
Dr. Aloka Srinivasan
Vice President, Regulatory Practice
Dr. Akhilesh Sharma
President & Chief Medical Officer
Dr. Akshaya Odak
Head, Regulatory (Biotech)
Dr. Deepa Arora
Vice President, Pharmacovigilance & Global Head, Drug Safety & Risk Management
Deputy Drugs Controller (Goa)
Central Drugs Standard Control Organisation (CDSCO)
Dr. Raphael Nudelman
Director-Chemical & Computational Toxicology
Teva Pharmaceutical Industries Ltd.
Dr. Anurita Majumdar
Executive Director, Medical
Pfizer Essential Health
Chief Executive Officer (CEO)
Insight systems Inc.
Senior Vice President and Head, Gene Therapy and Clinical Research
Reliance Life Sciences Pvt. Ltd.
Senior Vice President, Manufacturing Sciences & Technology
Dr. Reddy's Laboratories
Head, Regulatory Affairs, South Africa SEA Region
Vice President, Technical
Dr. Partha Roy
Vice President, Technical
Dr. Rajashree Devarakonda
Vice President-India & Asia Pacific
Voisin Consulting Life Sciences
Dr. Ravisekhar Kasibhatta
Senior Vice President - Clinical Research
Rens van den Boomen
Dr. Shubhadeep Sinha
Senior Vice President & Medical Director
Dr. Siegfried Schmitt
Senior Director International
Biosimilar Medicines Group, Sector group of Medicines for Europe