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5th Annual Pharma Legal & Compliance Summit, 2016

Lex Witness is proud to present the 5th Annual Edition of Pharma Legal & Compliance Summit, 2016.

Date: 7th October, 2016
Venue: Novotel Juhu Beach, Mumbai

The Indian Pharmaceutical Market - A Background:
The Indian Pharmaceutical space is inevitably one of those sectors of the India Inc. that has made its mark and attention at a global level. Not only has it spearheaded the poised approach towards creating global benchmarks in terms of revenues, it has also reached a yet another pedestal for the alikes to follow.

The Lex Witness Pharma Legal & Compliance Summit over the past years has become a signature emblem in itself for the industry stakeholders to share their views and deliberate upon various legal and regulatory spheres of the past, current and future roadblocks that the Indian Pharma Sector has been through.

Keynote Session: The Big Indian Pharma Regulatory Rhymes

  • USFDA - Make in India - are we getting it right?
    • Business Margins - The Street & Stocks Fever - Valuation Games
    • Data Integrity Concerns of Pharma Manufacturing Sites in India
    • USFDA Warning Letters - Strategic & Preemptive Approach Ahead - Post Audit Actions - Perspectives & Challenges
    • Implementation of Quality by Design and Importance of doing it right all the time!

  • Indian Calling Now!
    • Good Manufacturing Practices, Good Supply Practices
    • Are Indian Pharma Companies. preferring Foreign Manufacturing Lands?
    • The Ban on 344 FDC Drugs - In & Out - A Detailed Perspective
    • In Focus - Section 26(A) of the Drugs and Cosmetics Act, 1940
    • NPPA DPCO Drug Pricing Fevers, National List of Essential Medicines (NLEM) - Impact Assessment
    • Amended Guidelines with respect to Recalling, Repackaging and Relabeling
    • The GST Connect - Drug Pricing Direct Relation?
    • The Katoch Committee Insights

  • Competition Law - Fairplay or Not?
    • Product Hopping - An Unhealthy Competition Breeder?
    • Case Study - COMPAT Whips CCI - The Alkem Order Case Study

  • GST - A Welcome Waiver
    • The GST Connect - Drug Pricing Direct Relation?
    • Way Forward - Concessional Structures, Rebates etc., Simplified Tax Structure & Operational Efficiency
    • Level Playing Field for Pharma Companies
    • Addresses Inverted Duty Structure
    • Lower Logistic Costs

  • E-Discovery - Saviour for the Pharma Sector?
    • Importance of E-Discovery as a Tool, Financial Saviours via E-Discovery Processes
    • Litigation Risks with respect to E-Discovery Preparedness
    • Critical E-Discovery Mandates in IPR

  • Clinical Trials
    • Recent Ease of Regulations - Welcoming Global Researchers
    • Removal of Cap - 3 to Unlimited, Sites - Relaxed norms for Hospitals etc.
    • Wishlist - Waiver and other Unheard Recommendations

Registration Fees:

No. of Delegates


Law Firms & Solution Providers

International Law Firms & Legal Service Providers

1 Delegates

INR 10,000

INR 12,000

US $350

2 Delegates

INR 18,000

INR 20,000

US $325 per delegate

3 Delegates

INR 24,000

INR 27,000

US $300 per delegate

4 or more

INR 7,500 each

Taxes Extra as Applicable

Please Note:

  • 15% discount for first 25 registrations
  • 10% discount for Lex Witness Subscribers, SILF and ICCA Members
  • No 2 discounts can be clubbed together

The registration fee includes Summit Kit, access to all speakers' presentations, certificate of attendance and a complimentary copy of Lex Witness Magazine.

Payment Details:
Payment by Demand Draft or cheque should be made in favour of "SriGro Interactive Pvt. Ltd." addressed to:

Mr. Akshay Alagh
SriGro Interactive Pvt. Ltd.,
# 426, 2nd Floor,
M.G. Road, Ghitorni,
New Delhi - 110030
Phone: +91-11-66569797

Ms. Bhupinder Kaur
Phone: 011-66569793, +91-9654155065

Ms. Neelima Maheshwari
Phone: 011-66569793, +91-8800841600

Lex Witness - India's 1st Magazine on Legal & Corporate Affairs
Unit No 426, 2nd Floor,
MG Road, Ghitorni,
New Delhi - 110030
Phone: 011-66569793

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