UNIQUITY India 2016 was a one-of-a-kind, complimentary, all-day conference to gain insight and best practices on pharmaceutical serialization, track and trace, and anti-counterfeiting solutions.
The UNIQUITY conference offered a lineup of superb speakers, industry insights, and a panel discussion on global serialization and traceability regulations by one of the most renowned experts in the field, Dirk Rodgers.
UNIQUITY INDIA 2016 attendees came away with a fuller understanding of the various mandates, including most importantly the DSCSA law, and discovered answers to some very thorny issues that may be affecting their compliance fulfillment journey.
UNIQUITY INDIA 2016 promises to be both insightful and educational to Indian pharmaceutical leaders, given the focus on regulatory affairs and effective technologies needed to achieve full global compliance.
Shri Sudhanshu Pandey, IAS
Joint Secretary, Ministry of Commerce and Industry
The UNIQUITY INDIA 2016 agenda offered a balanced set of presentations by senior Indian government officials who are responsible for policy formulation, along with talks by international experts on serialization, traceability and anti-counterfeiting. A unique aspect of this conference was the regulatory session and panel discussion, aimed at ensuring attendees are well informed and compliant on various global regulations, especially with regard to the US DSCSA law.
Morning sessions were devoted to general issues concerning regulatory compliance, where Indian government officials discussed current and future mandates that will further assist in managing the pharmaceutical supply chain, while reducing the trade in counterfeit drugs. Presentations on the deployment of effective technologies aimed to ensure global regulatory compliance in a unified, versatile and cost-effective manner.
The afternoon session, led by Dirk Rodgers, was devoted to informing attendees of detailed aspects of the US DSCSA law, compliance requirements, mandated deadlines, hidden complexities, and key components of the law that are pertinent to Indian exporters. This interactive workshop addressed serialization challenges for exporters, answering questions, and preparing for the larger set of unfolding global regulations in the future.
|08:00||Registration & Refreshments|
Speaker: Robert DeJean
CEO | Systech
|09:45||Special Lecture – Anti-Counterfeiting and Consumer Protection:|
Serialization and Traceability in the India Context: Perspectives and Insights of a Regulator
Speaker: Hemant Koshia, PhD
Commissioner | Food & Drug Control Administration
|10:15||Special Lecture – India Export Regulations:|
The Role of Public Policy and Private Enterprise in the Global Fight Against Counterfeit Medicines
Speaker: Ms. Anice Joseph Chandra
Director | Ministry of Commerce & Industry
|11:15||Industry Insights – Global Compliance:|
The Challenges to Compliance Fulfillment of Global Regulatory Mandates
Speaker: Arun Gupta
Strategic Advisor | Systech
|11:30||Technology Solutions and Insights – Part 1:|
The Total Systech Solution Stack and its Unique Set of Benefits to the Indian Pharmaceutical Industry
Speaker: Avi Chaudhuri
Senior Global Partner | Systech
|12:15||Regulatory Insights Preview:|
Global Regulation Summary and Review of Afternoon Regulatory Workshop
Speaker: Dirk Rodgers
Regulatory Strategist | Systech
|12:20||Lunch and Networking|
|13:30||Regulatory Workshop: Part 1|
Global Serialization and Traceability Regulations — What Indian Exporters Need to Know, and Do!
Host: Dirk Rodgers
Regulatory Strategist | Systech
|14:30||Special Lecture – Developing a Strategy for Compliance:|
How to Bridge the DGFT/DAVA Mandate with Global Serialization Regulations
Speaker: Arjun Guha Thakurta
Director Operations | Life Science Consulting Pvt Ltd a Conval Group Company
|15:30||Regulatory Workshop: Part 2 Panel Discussion|
Global Serialization and Traceability Regulations — What Indian Exporters Need to Know, and Do! (continued)
Host: Dirk Rodgers
Regulatory Strategist | Systech
|16:30||Technology Solutions and Insights – Part 2:|
Optimizing the Value of Your Track and Trace Investment to Ensure Full Regulatory Compliance
Speaker: Jim Lee
VP Product Management | Systech
|17:15||Afternoon Beer & Wine Social Networking|
ANICE JOSEPH CHANDRA
Ministry of Commerce & Industry
Government of India
Ms. Chandra directs the track and trace programme, implemented by the Department of Commerce, for the promotion of Brand India, ensuring that spurious health products are not exported under a “Made in India” label. She continues to interact with pharmaceutical stakeholders at all levels to promote the cause of consumer safety.
Ms. Chandra is directly involved in India’s bilateral and multilateral free trade negotiations, India’s implementation of the Trade Facilitation Agreement of the WTO, and the export oriented initiatives of the Pharma Sector, including the Medical Equipment Sector. She is an accredited expert of the World Customs Organisation, the Montreal Protocol, and the Cartegena Protocol on Bio Safety.
A key part of Ms. Chandra’s current portfolio is in the field of healthcare, where she plays a pivotal role in the DGFT export regulation for serialization, barcoding, and traceability. She has been responsible for drafting the various DGFT notices that have come to guide the industry over the past several years.
HEMANT KOSHIA, PhD
Food & Drugs Control Administration
Government of Gujarat
With over 30 years of experience in regulatory affairs in both government and industry, and as Commissioner of the FDCA, Dr. Koshia plays a pivotal role in transforming the pharmaceutical sector in Gujarat to emerge as a favorable investment destination with proactive and pragmatic approaches.
He leads a cross-functional team of diverse regulatory experts to implement and enforce applicable regulations and oversee thousands of drug manufacturers and over thirty thousand sales units in the State of Gujarat. Dr. Koshia is a passionate advocate of consumer safety and has implemented several major initiatives in his state focused on pharmaceutical product governance.
Dr. Koshia continues to play a key role in regulatory policy and advocacy in India and international markets, having recently chaired the Task Force to advise the Ministry of Health and Family Welfare on the optimal path to rolling out a national consumer protection program against the menace of counterfeit drugs.
ARJUN GUHA THAKURTA
Life Science Consulting Pvt Ltd a Conval Group Company
Mr. Thakurta has played a vital role in assisting pharmaceutical clients with compliance-readiness planning and validation to minimize risk of business and production process interference in a manner consistent with applicable local or global regulations.
Mr. Thakurta has over 19 years of experience in production management, quality assurance, strategic operations and risk management, computer systems validation, track and trace project management, validation and information security, and BCP/DRP.
In his lecture, Mr. Thakurta will provide his perspective on the DGFT/DAVA mandate for export of finished drug formulations, which is already in effect. This is a bridge many pharmaceutical companies must adhere to and cross as they race towards meeting the obligations for parent-child item relationships, along with reporting in the DAVA Portal. He will explain the specific changes that drug manufacturers must make to meet compliance and ensure the databases for other global regulations remain unaffected. The key focus of this session will be on providing insights into the complexities that exist and how to achieve compliance by developing a custom strategy for meeting the diverse compliance regulations.
Mr. Rodgers is widely acknowledged to be one of the global experts on the current and emerging set of pharmaceutical regulations on serialization and traceability. He is the founder of RxTrace.com where he writes regularly in exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards, and regulatory compliance.
Mr. Rodgers has worked as a consultant, software architect and automation engineer during a career spanning 30 years. In 2002 he became employed by Cardinal Health, one of the big 3 U.S. drug distributors, where he studied many approaches to applying serialization and track & trace technology to solve supply chain integrity problems and improve efficiencies.
Mr. Rodgers will share his vast knowledge of serialization and traceability regulations. He has designed a unique workshop for Uniquity India, which will allow attendees to fully understand and grapple with the many complexities of the various global regulations, with focus on US DSCSA, and address their key concerns and questions in moving forward.
AVI CHAUDHURI, PhD
Senior Global Partner
Dr. Chaudhuri has over ten years of experience in the field of serialization, traceability, and consumer protection from counterfeit drugs. He introduced the very concept of serialization to the Indian pharmaceutical industry ten years ago and helped to create a national SMS program for drug verification.
His work in this field began in 2004 when Dr. Chaudhuri became a victim of a counterfeit drug while traveling in India. Since then, he has been a strong advocate for consumer empowerment. He authored CII’s highly acclaimed manual on technology solutions that played a pivotal role in the DGFT’s eventual conceptualization and implementation of a serialization program to protect drugs exported from India.
Dr. Chaudhuri will provide his perspectives on how Systech’s total stack of technology solutions is ideally suited for the Indian pharmaceutical industry as it moves toward compliance with a varied and complex set of serialization and traceability regulations in key global markets.
Vice President, Product Management
Jim Lee leads global product management, new and existing solutions development, and rapid deployment of Systech’s supply chain technology.
Prior to joining Systech, Lee was vice president of product management and strategy for IBM’s Integration and Governance, a key pillar within IBM Information Management, which comprised of business governance, data integration and quality, real-time data movement, and data lifecycle management with security and privacy across platforms.
If you are interested in more information or have questions about the conference and presentations, please let us know.