Agenda

   
   
08:30 a.m – 9:50 a.m : Registration –Breakfast –Networking
   
10:00  a.m : Opening Remarks / Welcome
 
Session 1:
   
10:00 a.m - 10:40 a.m :
Mr. Deepak Kallakuri - Product Marketing Manager, Vision Systems Marketing - Cognex Corporations.
   
Description: This session will describe how Cognex’s breakthrough vision and identification technologies can offer unparalleled accuracy, repeatability and flexibility to pharmaceuticals manufacturers, faced with the on-going challenges of mass-serialization, at the lowest cost of ownership in the industry.

Additionally, this session will clearly demonstrate that at the machine level, the use of smart camera vision systems offers undisputed advantages in terms of performance, low cost, ease of deployment and ease of maintenance, that can significantly and sustainably help pharmaceuticals manufacturers to successfully comply with global and local regulations.
   
Speaker Background :
Mr. Deepak Kallakuri is a Product Marketing Manager at Cognex. Mr. Kallakuri is responsible for the product strategy and road map of industry-specific products like In-Sight® Track and Trace for the pharmaceuticals market.

During his career, Mr. Kallakuri held leadership roles in product development and marketing at various technology companies. Mr. Kallakuri has a B.E. in Electronics and Instrumentation Engineering from Andhra University in India and a M.S. in Electrical Engineering from New Mexico State University. He also holds a M.B.A. in marketing and strategy from Cornell University.
   
Session 2 :      “ Unhealthy Medicine ! Comprehensive Strategic Plan for the stake holders to face the challenge ”
   
10:40 a.m - 11:20 a.m : Mr. C.P.Shastry - B.Pharm., MS, MDP (Marketing Strategies), R. Ph. - Pharma Synergies.  
   
Description: The menace of counterfeit drugs in the world is a central challenge to the national and international public health systems and also a direct threat to the individual health and prosperity of the global citizens.

The involvement of other nefarious actors in the counterfeit drugs production and trafficking is also threat to the national and international security system and that of the global citizens.

The estimated sales of counterfeit drugs are over US$ 70 Billion.

It is imperative that

1. All stakeholders need to be involved in facing this global challenge

2. There should be a strategic action plan for the stakeholders to counter it, across the nations.

It may also be necessary to re-phrase the definition of counterfeit drugs by the supranational bodies.

1. To make it simple, easy-to-interpret to ensure that the regulatory authorities and all the stakeholders to take the right actions.

2. To have broader consensus among the stakeholders across the nations to allay the apprehension about the possible misuse of the law due to the ambiguity and misinterpretation of the definition.

A comprehensive strategic plan for the stakeholders to face the challenges posed by counterfeit drugs will be discussed in this presentation.
   
Speaker Background :
Mr. C.P.Shastry is B.Pharm., MS, MDP (Marketing Strategies), R. Ph. and has a strong knowledge of Global Pharmaceutical Industry, Emerging Markets / Business Opportunities, Market Research Reference Sources, IPR, cGMP Accreditations, Quality Systems (ISO) and Regulatory Compliances (CEP/DMF).

He has a Experience of

• API / Drug Intermediates / Formulations / PFI (DC and Pellets) / Nutraceuticals & Feed Supplements and Herbals Marketing.
• Strategic Alliances
• Technology Transfers
• Custom Synthesis
• New Products Identification and Successful Commercialization.
• Participation in Global Bids
• Field Operations
• Product Management / Sales Promotion
• Training & Development
 
11:20 a.m – 11:50 a.m : Tea Break/Networking for General Audience &  B2B Meets on Reserved Sponsor/Table Top Tables
   
Session 3:
   
11:50 a.m –12:30 p.m Mr. Samir Vasavada -Controller - External Manufacturing - Abbott India Ltd.
   
Description: Mr. Samir Vasavada talk
   
Speaker Background :

Mr. Samir Vasavada   is MASTER OF PHARMACY from University of Bombay.Working as Controller - External Manufacturing in Abbott India Ltd. Since April 2002 . A global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products in 130 countries worldwide.

 

He is responsible for :

  • Direct, supervise, control and monitor Techno-commercial and legal functions of Outsourcing activities in India.
  • Monitor contract and loan licence manufacturing sites
  • Direct and control weekly , monthly and yearly production plans

 

   
   
Session 4:    "Combating Counterfeiting of Drugs and Pharmaceuticals – The Legal Arsenal Available"
   
12:30  p.m -1:10 p.m : Henal Vakharia - Partner, Kochhar & Co. Mumbai
   
Description:

Counterfeiting of drugs and pharmaceuticals is mushrooming as an organized crime and counterfeit pharmaceutical products result not only in substantial economical loss to manufacturers and corporations but also pose as a significant threat to the health of innocent consumers. Our presentation aims to highlight the following:

  • the varied legal provisions contained in laws governing intellectual property, customs, drugs and cosmetics etc.
  • the stand taken and precedent set by the judiciary in such circumstances;
  • other ancillary measures implemented (for instance the whistle blower scheme, affixing of holograms on the products, etc.); and
  • instances of measures adopted by several corporations (within India and overseas) to tackle counterfeiting of their goods (use of coding and identification systems and overt and covert features to authenticate products where such systems and features are known only to that particular organisation).


ITS TIME TO COUNTER-ATTACK THE DRUG COUNTERFEITERS WE ENCOUNTER


   
Speaker Background :
Henal is a qualified Advocate and has been practicing in Mumbai for over 17 years. She is also qualified as a Solicitor from Supreme Court of England and Wales. She have advised and represented clients on a wide range of issues and involving Intellectual Property Rights (IPR).

Henal has vast experience in handling Intellectual Property Rights prosecution and litigation matters. She has been advising national and international entities on intellectual property right issues. She has also advised clients on developing strategies in relation to optimization, creation, management, protection, exploitation and commercialization of various kinds of intellectual property rights. She also works closely with a network of foreign associate firms across the globe, registered to practice in respective foreign countries, in order to obtain registration of various intellectual property rights and to initiate enforcement actions in such countries.
   
1:10 p.m – 2:10 p.m : Lunch /Networking for General Audience &  B2B Meets on Reserved Sponsor/Table Top Tables
 
Session 5 :   "AntiCounterfeiting during Clinical Trials: Never too Early to Start"
   
2:10 p.m -2:45 p.m : Dr. Kiran Marthak - Lambda Therapeutic Research Ltd.
   
Description: The public perception is that counterfeit medicines are predominantly in the area of lifestyle drugs that treat non-life threatening conditions (e.g. erectile dysfunction and weight loss drugs); however, the UK MHRA has detected counterfeit products covering a number of chronic conditions, and cases of counterfeit medicines detected in the legitimate supply chain from clinical trials through wholesale to the Point of Dispense (PoD), with nine cases of recalled counterfeit medicine identified in the past three years having reached the patient or pharmacy.

Counterfeit products have been detected at the clinical trials phase of development, some form of supply chain security or product authentication measures should be in place at this early stage.

“This session will discuss that, not well known to most, counterfeit samples are encountered during pharmaceutical clinical trials.

Dr. Kiran Marthak will discuss how counterfeits happen and how they could impact clinical research.

Additionally, he will touch on what risks counterfeits pose to patients, clinical trial sponsors and the entire pharmaceutical drug development life cycle if not detected early and eradicated. He will complete his session by discussing industry best practices and strategies in the constant battle against counterfeits early in the drug development process well before manufacturing and distribution”
   
Speaker Background :
Dr. Marthak is one from Governance Committee of Lambda Therapeutic Research Ltd. and has more than 25 years of active participation in the field of clinical research and a number of scientific qualifications and publications to his credit. Dr Marthak has an M D medicine awarded from Dr. Grant Medical College and is also a Business Management Degree holder.

Dr Marthak is actively involved with regulatory authorities like US FDA, UK MHRA, China SFDA, South Africa MCC, MHCW and India –DCGI He is a Member of the Medical Committee- Indian Drug Manufacturer’s Association, a Member-India Task Force- DIA, USA, a Founder Member- Clinical Research Institute, India and a Member of the Delegation- Gujarat Government, Vibrant Gujarat.
   
   
Session 6 :
   
2:45 p.m -3:25 p.m : Ms. Faguni - Regional Sales Manager -Sproxil Inc.
   
Description: Brand and product pirates in emerging markets pose a significant risk to legitimate manufacturers and brand owners, leading to brand degradation, decrease in sales, consumer purchasing apprehension and exposure to lawsuits. Prevalence of counterfeit drugs is pegged at 10% to 30% in the developing world, hence making it a serious issue. According to US based Centre for Medicines in the Public Interest (CMPI), approximately $75 billion worth of counterfeit drugs are being sold annually. The need of the hour, thus, is for brand owners to ensure they are protecting their products and brands and have a proper track and trace solution for their products.

This session is aimed at understanding the various ways counterfeiting can be tackled by brand owners. By implementing consumer backed authentication services, manufacturers and distributors of pharmaceutical products can protect their consumers from fake or spurious products and also boost their sales by making counterfeiting economically unviable for the counterfeiters. Cascading AuthenticationTM can help manufacturers ensure trust in their handling agents. With fragmented supply chains that are typical of developing economies, consumer backed authentication can create the desired ‘push-back’ effect required to ensure that only genuine products move along the supply chain. This session will help in understanding how CBA can minimize the possibility of counterfeit products compromising legitimate brand equity.
   
Speaker Background :

Ms. Faguni Jain is a Regional Sales Manager, handling sales for Southern and Western Regions of India for the Indian operations of Sproxil, Inc. She helps companies understand and implement Sproxil’s Mobile Product Authentication technology which has been proven to tackle counterfeiting in cash based societies. An engineer and an MBA, Faguni has previously worked with Johnson & Johnson Medical Devices and Diagnostics as a sales and marketing professional.

   
3:25 p.m – 4:00 p.m : Tea Break/Networking for General Audience &  B2B Meets on Reserved Sponsor/Table Top Tables
   
Last Session
Panel Discussion :
PANEL Discussion (Audience Participation invited**))
   
4:00 p.m –5:00 p.m : Panel Moderator : Mr. Ram Balani-CEO/Founder-FDASmart Inc.
   
Panel Discussion Description: This panel will probe panel members on various topics related to the global challenges and possible solutions to win the war against pharmaceutical drug counterfeits.

Past ( Jan 2011 ) DGFT barcoding requirement announcement for Indian drug exports and recently the DCC/DCGI mandates for ALL INDIA drug manufacturers will be highlighted during the panel from various stakeholder perspectives.
   
 
Mr. Deepak Kallakuri- Product Marketing Manager, Vision Systems Marketing -Cognex Corporations.
Henal Vakharia - Partner, Kochhar & Co. Mumbai
Ms. Faguni - Regional Sales Manager -Sproxil Inc.
Dr. Kiran Marthak - Lambda Therapeutic Research Ltd.
Mr. Samir Vasavada -Controller - External Manufacturing - Abbott India Ltd.
Mr. C.P.Shastry - B.Pharm., MS, MDP (Marketing Strategies), R. Ph. - Pharma Synergies.