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4th Annual Pharma Legal & Compliance Summit 2015

4th Annual Pharma Legal & Compliance Summit 2015

Lex Witness proudly presents the 4th Annual Edition of Pharma Legal & Compliance Summit 2015.

Date: 16th October, 2015
Venue: The Leela, Mumbai

Download Brochure, Registration Form

The upcoming edition focuses on various legal and regulatory challenges the Indian Pharma Sector has been going through across domains like Compliance, IPR, M & A and Regulatory.

The summit is framed around the opinions and suggestion of the industry experts themselves, which Team Witness has gathered through an aggressive research campaign. We hope that attending the summit shall help you and your colleagues to face the challenges that have gradually become a nightmare for the industry.

Summit Concept:

The Indian Pharmaceutical Market - A Background:
The Indian pharmaceuticals market is third largest in terms of volume and thirteen largest in terms of value, as per a pharmaceuticals sector analysis report by equity master. The market is dominated majorly by branded generics which constitute nearly 70 to 80 per cent of the market. Considered to be a highly fragmented industry, consolidation has increasingly become an important feature of the Indian pharmaceutical market. India has achieved an eminent global position in Pharma Sector. The country also has a huge pool of scientists and engineers who have the potential to take the industry to a very high level.

The Indian pharmaceutical industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years, as per India Ratings, a Fitch Group company. Indian pharmaceutical manufacturing facilities registered with US Food and Drug Administration (FDA) as on March 2014 was the highest at 523 for any country outside the US. (IBEF)

Unfolding the Legal Hassles & Challenges:
The Indian Pharmaceutical Industry has been one of the most vibrant and forward moving business fabrics of the economy. At the same time, the industry has been through roadblocks in terms of the stringent legal and regulatory environs of the country.

The summit kick-starts "compliance" as its key mandate and focus as its Keynote Session. The session encompasses various aspects right from the manufacturing hubs to the doorstep of pharmacists. On the other hand, the digital boom hasn't been so well for this part of the India Inc. as players struggle yet to understand the regulatory aspects attached. And that's not all would there be a player who would confess non-compliance - if so why and how!

Creating a property is where the wars begin from. In today's scenario of a rat race across industry sectors, protecting a creation for successful monetization happens to be the key to standing apart. The session elaborates on all possible strata of "Intellectual Property" right from the phases of implementing it and sustaining the commercial value. Having said that, counterfeiting happens to be struggle even today and unfortunately for the creators!

M & A and FDI - talks of the legal corridors! India Inc. has witnessed and set benchmarks via noticeable mergers and acquisitions in place. Whether it is the pre-existing legal liabilities of an entity being eyed on for acquisition or a typical case of a merger, it is indeed a fine eye that's required to keep all checks in sync. Can there be master check list to be followed? Let's see what the experts have to say.

The "Patents" ecosystem in India has been as innovative and inventive as the nature of the sector itself. The legal aspects around the patenting complexes include not one but many areas of complications and challenges at the same time. Whether, the introduction of a new product or licensing as a subject, the sector needs clarity and global intellect in place to combat the global pressures that India is currently facing. An overview of the topical talk points.

"Regulations" by the literal sense intends at controlling and not limiting. Is there a misbalance between sentiments of a patient and that of the industry? Is there a need of relooking at Regulations from a global perspective? Howsoever, complicated and complexed the situations may be, it is inevitable for the industry to adopt and comply with the regulations in place, and keeping all business interests in place as well. Listen to the veterans to know the award winning secrets.

Keynote Session:

Demystifying Compliance:

  • Good Manufacturing Practices / Good Supply Chain Practices
  • Anti-Trade / Bribery / Corruption - FCPA, UK Anti-Bribery & PCA
  • Product Promotion - UCPMP & Global Perspective
  • Voluntary Disclosure of Non - Compliance
  • Pharma covigilance
  • Product Liability Compliance

Unleashing the Sciences of Trademarks & Copyright

  • Trademarks Enforcement Issues
  • Trade Dress
  • Madrid Protocol in India
  • Copyright
  • INN Names
  • Trade Secrets

M & A and FDI Rides of the Indian Pharma Sector

  • Due Diligence
  • Regulatory Bodies - FIPB / DIPP / CCI
  • Challenges in executing a M & A Transaction

An Insight into the Current Patent Scenario in India

  • Patents as incentives for R & D
  • Patent Criteria
  • Patent Enforcement
  • Compulsory Licensing
  • Voluntary Licensing - In Licensing / Out Licensing
  • Compliance Protocol of the Indian Patents Act
  • Challenges of Introducing a New Product
  • Global Pressures on Indian IP Policies
  • IP Portfolio - Identify, Protect, Valuate, Monetize
  • Data Exclusivity

The Regulatory Sagas & the challenges within

  • Clinical Trials
  • Drug Price Control Order 2013
  • Competition Act
  • Co Manufacturing & Co Branding Practices
  • D & C Act - Counterfeiting (Misbranding & Adulteration)
  • UCPMP & MCI Guidelines

The summit has different registration modules for Corporates and Law Firms & Solution Providers (Domestic as well as International). Please opt for the relevant registration option and follow the simple steps ahead.

For your convenience we have 3 modes to register as a delegate;

  • Register Online
  • Register via Email
  • Register Offline

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

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 INR bank 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,
MG Road, Ghitorni,
New Delhi - 110030
Phone: +91-11-66569797

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