7thAnnual Global Pharma Regulatory Summit 2018

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.

Advisory Board Members & Speakers

Glimpses of 2017

Key Topics

USA Focused
  • Overview of regulatory landscape of data integrity
  • Elemental and Genotoxic Impurities: A regulatory perspective
  • Life Cycle Management of Products - Quality and Regulatory Perspectives
  • Biosimilar regulatory requirements by FDA
  • An overview on regulations of complex and differentiated generics
EU Focused
  • Bio-similar regulatory landscape in EU
  • IDMP Compliance Challenge and Regulatory Information Management
  • Implications of eCTD submissions
  • Pharmacovigilance regulatory landscape in EU: Implementation and challenges
  • Overview of regulatory landscape of data integrity
  • GMP guidelines for EU market
  • Implications of Brexit on global pharmaceutical industry and India
US, India and RoW Focused
  • First cycle approval of ANDAs - from a possibility to reality
  • Regulatory considerations related to 505b(2) pathway
  • Current trends in ANDA and DMF reviews: Challenges to the industry
  • Japan/China: Regulatory pathways and guidelines
  • Regulatory requirements for Good Clinical Practice (GCP) compliance: India perspective
  • Regulatory landscape in Africa and Regulatory Harmonisation Program
  • Pharmaceutical regulatory environment: Challenges and opportunities in Gulf

Event Partners

Silver Partner

Exhibit Partners

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