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This conference brings together pharma and healthcare supply chain leaders to learn more about upcoming DSCSA implementation milestones. Innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the pharma and healthcare supply chain. This event also overviews and integrates the business and technical problems that pharmaceutical companies should be aware of in order to fight the major global problem of counterfeit medicines. In addition to discussion of the problems, this conference addresses Supply chain security, serialization, track and trace analytical techniques scientists use to detect counterfeits and identifying solutions to the threat of counterfeit medical products.
HSI
NICOLE JOHNSON, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
Special Agent (SA) Nicole Johnson is a Homeland Security Investigations (HSI) National Program Manager for the Intellectual Property Unit (IPU) within the National Intellectual Property Rights Coordination Center (IPR Center). In this position, SA Johnson manages multiple programs that combat counterfeit products impacting public safety such as:
• Operation Apothecary – counterfeit pharmaceuticals
• Operation Body Armor – counterfeit medical devices, surgical supplies, and cosmetics
• Operation Genuine Valor – counterfeit medical supplies in the Veterans Affairs supply chain
• Operation Stolen Promise – counterfeit covid related products like masks, vaccinations, and fraud
SA Johnson works closely with Customs and Border Protection (CBP) and brand holders to identify bad actors, supply chain vulnerabilities, and government contract fraud, in addition to developing leads and providing investigative case support. Another significant IPU responsibility is leading training and outreach. The IPR Center combats counterfeits through public / private partnerships, requiring frequent communication with the brand holders, key stakeholders, and the public at large on best practices. Additionally, SA Johnson works globally to collaborate with and train law enforcement, prosecutors, and judges on current trends and standards of intellectual property violation enforcement.
In 2008, SA Johnson began her career with HSI and was stationed in Los Angeles, CA for 13 years. During her tenure in Los Angeles, she conducted complex investigations into human trafficking, gangs and organized crime, intellectual property rights, and trade-based money laundering. Based on her interest in public safety investigations, she transferred to the IPR Center in 2022 to manage programs that directly affect the health and safety of consumers and medical patients.
SA Johnson holds a Master’s in Social Ecology; Law, Criminology, and Society from the University of California, Irvine, and a Bachelor’s in Cultural Anthropology from Vanguard University of Southern California (VUSC). SA Johnson is also an adjunct professor at VUSC and instructs courses on identifying and investigating human trafficking for the Global Center for Women and Justice. SA Johnson is a Colorado native and enjoys the outdoors.
HSI
BYRON JONES, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
• Special Agent (SA) Byron M. Jones is a Homeland Security Investigations (HSI) National Program Manager for the Government Supply Chain Investigations Unit (GSCIU) within the National Intellectual Property Rights Coordination Center (IPR Center). In this position SA Jones is responsible for facilitating comprehensive supply chain risk management across the federal government by revitalizing and leveraging key public and private partnerships, modernizing existing infrastructure and processes, and integrating and analyzing interagency data sources to identify and combat threats to commodities entering the US Government supply chain.
• SA Jones is responsible for an HSI national led program with respect to counterfeit, substandard and diverted medications and medical devices from entering the United States Government supply chains by leveraging the relationships of multiple federal agencies, industry partners and academia.
• SA Jones began his law enforcement career in 2008 with the 839 Session of the United States Border Patrol and was assigned to the Fort Brown, TX (Brownsville) and Swanton, VT Border Patrol stations. SA Jones then transferred to the Port of Brownsville, one of the largest international ports of entry in the U.S., responsible for facilitating legitimate trade through a Seaport, Airport and land borders with U.S. and Customs and Border Protection (CBP) as a CBP Officer and a Supervisory CBP Officer.
• In 2016, SA Jones transferred to HSI as a Special Agent and has been assigned to the Baltimore and Brownsville field offices conducting complex investigations in narcotics, money laundering / financial crimes / embezzlement, and commercial fraud prior to his assignment at the IPR Center. SA Jones regularly provides extensive training to new and senior agents at various academies and has also conducted a variety of training and outreach to many foreign law enforcement, government, and private partners on a wide array of topics.
• SA Jones holds a Master’s in Business Administration (MBA) from the University of Texas Rio Grande Valley, a Bachelor in Business Administration with a minor in Paralegal Studies from American Military University and a Graduate Certificate in Spanish and Latin American Studies from the University of Texas Permian Basin. SA Jones is currently pursuing his Doctoral degree in Business Administration. SA Jones also served as an officer in the United States Air Force Reserve. SA Jones is a native of Buffalo, New York.
DEA
TODD BOYETT, Chemical Investigations Section, Diversion Control Division, Drug Enforcement Administration (DEA)
Bristol-Myers Squibb
SCOTT HUFFMAN, Associate Director, Forensics & Innovative Technologies, Bristol - Myers Squibb
Sanofi
CHIRAG SHAH, Director of Supply Chain Security, Sanofi
During Chirag V Shah’s career in Supply Chain / Product Security, he has worked in both Pharmaceutical/Biotech and Consumer Goods industry. His career has included work in the supply chain management consulting. For the 19 years to date within Sanofi, Chirag has developed a strong network with in Global Industrial Affairs / Global Supply Chain for Pharma, Pasteur, Genzyme and Consumer Health. He has strong knowledge in supply chain principles, systems, product & supply chain security and anti-counterfeiting technologies. Chirag is also the point of contact for US Customs and Border Protection’s Customs Trade Partners Against Terrorism for both entities of Sanofi’s – Sanofi US Services Inc. and Sanofi Consumer Healthcare. Chirag is a member of Transported Asset Protection Association (TAPA) and the Waiver and Standards Committees and Certified Trainer for Facilities & Transportation Security Requirements, member of Pharmaceutical Cargo Security Coalition (PCSC) and has graduated from Sanofi’s Emerging Leadership Program. Lastly, he is a Six Sigma Greenbelt from Sanofi.
Chirag for the past 11 years and currently is the Director, Global Product & Supply Chain Security for Sanofi. He is responsible for ensuring the integrity of Sanofi products (biologic’s, pharma, vaccines and consumer health) from manufacturing to patients – an end to end program which includes working on way to prevent counterfeiting, hijacking, diversion and ensuring the supply chain is protected. Product life cycle risk management tools are used to minimize risk to the products throughout the supply chain. Currently, Chirag conducts Supply Chain Security Audits domestically & internationally, especially those that are governed under US Customs & Border Patrol’s Customs Trade Partnership Against Terrorism (CTPAT) which allows expedited entry into the US of imported Raw Materials, API, Bulk and Finished Goods. In addition, Chirag provides training to other Security colleagues around the world in order to expand the Supply Chain Security Audit program. Chirag chairs the North America Sanofi Business Security Committee, bringing a cross-functional team of Regulatory, Legal, Quality and Business Units to discuss Anti-Counterfeit, People Protection, Meeting Security and Information Security concerns. He also monitors along with North American Supply Chain, IT and Government Affairs compliance to the US Drug Safety Quality Act as it relates to Serialization. Chirag is also supporting his Canadian Supply colleagues for their application into Canadian Customs and Transport Canada government programs. Lastly, Chirag is the DEA Coordinator of record for R&D – monitoring ordering practices, inventory control (annually),
Animal Rights Extremist Activity Monitoring and Subject Matter Expert for Sanofi Security Labels for North America.
Prior to his current role, he was in North America Supply Chain & Distribution starting in 2005 till 2013, where he began as a Sr. Manager in Demand Planning and lastly there as Director of New Product Launches. He managed the supply for key products within the Diabetes, Oncology and MS – Lantus, Apidra, SoloStar, Taxotere, Jevtana, Zaltrap, Aubagio, Lemtrada for North America. He has launched many of these products in the US, by managing large cross-functional teams in order to have an expedited launch once FDA approval. He also managed Distribution projects from Distribution Center consolidation between Pharma and Pasteur, optimization projects etc.
Prior to Sanofi, Chirag built his supply chain experience at Mondeleze/Kraft/Nabisco in consumer goods – forecasting, production planning and in Supply Chain Management Consulting at Accenture.
Alnylam Pharmaceuticals
eSTARHelper (USA)
Ferring Pharmaceuticals
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
MorphoSys
CEM AYDIN, Associate Director - Team Lead Logistics and Warehouse, MorphoSys
Cem Aydin is a Supply Chain professional with 19 of experience in Logistics, Planning and Procurement. In his current role, he oversees transportation and warehousing as well as being system manager of Serialization, including projects and operational use of the system. Completed outbound serialization in 2022 and DSCSA upgrade projects in 2024.
He holds BS degree in Industrial Engineering and MSc. degree in Supply Chain Management. Cem has proven experience in establishing new departments and processes across organizations of varying sizes.
Rising Pharmaceuticals
Partnership for Safe Medicines
SHABBIR IMBER SAFDAR, Executive Director, Partnership for Safe Medicines
Ten Count Consulting
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Mark Karhoff is a Supply Chain and DSCSAConsultant and founder of Ten Count Consulting, LLC. Mark has 30 years of experience in program management, process improvement and supply chain solutions. Ten Count assists clients on system implementations and process to comply with DSCSA (Drug Supply Chain Security Act) including assessments and mock audits. He has served as a client representative with industry groups such as PDG (Partnership for DSCSA Governance), HDA, NABP, GS1, PDSA and FDA workgroups to establish standards and build alignment meet the unfolding US Law.He lives with his family in Chicago and believes in advancing corporate social responsibility through partnerships with not for profits. You can reach him at mark.karhoff@tencountconsulting.com
Hogan Lovells
LYNN MEHLER, Partner, Hogan Lovells
As Co-Head of the firm's Life Sciences & Health Care industry sector and Head of the Pharmaceuticals and Biotechnology practice, Lynn Whipkey Mehler advises clients on a range of FDA and DEA regulatory matters. She has worked extensively on the approval processes for new drugs and biologics; on safety issues that include Risk Evaluation and Mitigation Strategies (REMS); and on unique regulatory issues raised during the development and marketing of controlled substances.
Drawing on her 12 years with the FDA's Office of the Chief Counsel, Lynn has a deep understanding of the FDA. Her experience as the primary attorney handling all FDA issues related to controlled substances provides her with unique insights into both the FDA's and DEA's regulatory processes for controlled substances. She advised the agency on drug safety matters, including at approval and those leading to labeling changes, REMS, and even product withdrawal, and she applies that understanding to help clients create effective solutions for FDA regulatory matters.
Lynn has worked with a range of clients, getting their products approved, developing and modifying REMS, and negotiating shared REMS with generic applicants. She draws on her deep experience in the FDA approval process to represent pharmaceutical clients in formal dispute proceedings within the agency.
Having counseled the FDA on the Prescription Drug User Fee Act, she now guides clients in the submission of user fee waiver requests and helps them understand the agency's administrative management of drug applications. She has extensive experience in the FDA and DEA drug scheduling process and has worked with clients to effectively manage the process to minimize the delays to product launch. She has a deep understanding of the web of regulatory requirements governing the research and development of controlled substances and guides companies on matters from initial clinical trials to approval and marketing.
Representative experience :-
• Represent multiple innovator companies during the negotiation and development of shared REMS.
• Advising a pharmaceutical client in preparation for, during, and to a successful close-out of an FDA pharmacovigilance inspection.
• Advising a pharmaceutical client through the DEA scheduling process for controlled substances and to successful marketing of the product.
Awards and rankings :-
• FDA Commissioner's Award of Excellence
• FDA Commissioner's Award of Merit
• FDA Outstanding Service Award
Latest thinking and events :-
News : FDA advises on RWE non-interventional study use as evidence of effectiveness or safety - 21 March 2024
Press releases : Hogan Lovells Guides Mind Medicine Inc. on its US$175m Underwritten Offering of Common Shares and Concurrent Private Placement - 14 March 2024
Press releases :Hogan Lovells advises Perspective Therapeutics on a series of strategic transactions with Lantheus and a US$69 million follow-on public offering of equity securities - 26 January 2024
News : Key considerations for responding to a CREATES Act request - 26 January 2024
News : FDA explains “confirmatory evidence” for sponsors seeking approval based on a single clinical trial - 03 October 2023
News :New FDA Guidance on Psychedelic Drug Development - 26 June 2023
Meet and to network with your conference colleagues.
08:00 – Coffee and registration
09:00 – Morning Chair’s opening remarks
RAM BALANI, CEO / Founder, eSTARHelper (USA)
09:10 – Advanced Analytical Technologies for the Authentication of Suspected Counterfeit Drug Products
• As the first line of defense, supply chain security must be established and maintained. However, if it is breeched, a well-equipped and staffed analytical laboratory will be required to confirm the authenticity of drug products.
• Advanced analytical technologies can not only confirm the authenticity of a drug product, they can be used to determine the chemical makeup of those that are found to be true counterfeits.
• The chemical components found in a counterfeit may offer clues to the identity and location of the counterfeiters, and provide linkages to other incidents and cases.
• This information may then be used to strengthen the legal case against a counterfeiter.
SCOTT HUFFMAN, Associate Director, Forensics & Innovative Technologies, Bristol-Myers Squibb
09:50 – Serialization in the Pharma – Points to remember
• Tackling Counterfeit Medicines
• The Serialization Solution
• To consider – Cost, Resources, Right partner, Automation, Data Management & Exchange
• Understand better how to approach and prepare for a successful Track & Trace program
• Key for successful serialization of pharmaceuticals: data is the cornerstone
• How to ensure easy and secured data exchange with authorities and affiliates
• Adapting to the changing regulatory environment
JOSE CAMARA SANTIAGO, CEO, Camara Validation & Consulting Services
10:20 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com
10:50 – Morning Coffee & Networking
11:20 – Keynote Panel Discussion: Tackling Counterfeit Drugs: The Challenges & Possibilities
• Counterfeit Drugs: Challenges and steps taken to eliminate them
• As a company, where should you start to handle the situation better?
• Combating the rise in online counterfeit medicines
• Role of Pharmacist’s in to stop counterfeit drugs
• Importance in educating patients - Helping your patients to avoid counterfeit drugs
• Lessons to learn from RoW
Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Panellists
SHABBIR IMBER SAFDAR, Executive Director, Partnership for Safe Medicines
RAHUL SAIKIA, Head of M&A, Chief Strategy Officer, Rising Pharmaceuticals
NATE KREVOR, Managing Associate, Sidley Austin
12:10 – “New innovations of drug counterfeiters: online pharmacy marketplaces, fraudulent T3’s, alternative funding programs, and compounded APIs for sale on etsy”
SHABBIR IMBER SAFDAR, Executive Director, Partnership for Safe Medicines
12:40 – Networking luncheon / Exhibition Visit
13:50 – Customer Centric Supply Chain Strategy
• Resilient Supply Chain
• Order Promising
• Demand Planning
• Capacity Planning
• Material Supply Planning
• Detailed Scheduling & Inventory Planning
OPEYEMI ODUSAMI, Former Associate Director, Global Supply Chain Product Lead, Sanofi
14:20 – Topic TBC
CAMILLE DISS, CPO, EDGYN
14:50 – Afternoon coffee & Networking
15:20 – Panel Discussion with experts – Enhancing your Supply Chain - Building resilient supply chains in the evolving pharma environment
• Steps pharma supply should take to adapt to new DSCSA laws
• Strengthening and transforming the pharmaceutical supply chain
• How pharmaceutical companies should develop a reliable and sustainable supply chain?
• Anti-counterfeiting and supply chain security – Working hand in hand
• Verification methods at different points in the supply chain to ensure the integrity of your product
• How do counterfeit pharmaceuticals find their way into the supply chain? Solution
• Key obstacles / Overcoming challenges / Enhancing efficiency
Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Panellists
JIM MARSHALL, Director, Supply Chain, Alnylam Pharmaceuticals
CHIRAG SHAH, Director of Supply Chain Security, Sanofi
ASMITA KHANOLKAR, Sr. Director, Medical Device, Cambridge Pharma
OPEYEMI ODUSAMI, Former Associate Director, Global Supply Chain Product Lead, Sanofi
16:10 – Challenges in LATAM Region to migrate to e-labeling
URIMARA ARGOTTI, Regional Regulatory Policy LATAM Head, Roche
16:40 – Chairperson’s closing remarks and end of conference
16:50 – 18:00 – Networking Drinks Session
08:00 – Coffee and registration
08:50 – Morning Chair’s opening remarks
RAM BALANI, CEO / Founder, eSTARHelper (USA)
09:00 – “Securing a Resilient Supply Chain Through Dynamic Partnerships – Introduction to the Intellectual Property Rights Coordination Center”
NICOLE JOHNSON, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
BYRON JONES, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
09:30 – “Boosting DSCSA Regulatory Preparedness for FDA’s Drug Supply Chain Security Act Compliance with Microsoft Copilot Integrated Generative ChatGPT - 4 AI / ML”
• Why DSCSA was created by US Congress, brief history, overview of FDA DSCSA pilot project final assessment reports
• Who’s who and what’s what with DSCSA trading partner roles, some mandates apply to all drug industry stakeholders others not, l earning requisite trading partner roles challenging!
• Discuss why many remain unprepared highlighting the search gauntlet with US FDA.Gov website hosted regulatory contents (Guidance & 21 CFRs, abysmal metadata searching) vs. the fallback alternative with Google search -there’s better ways now
• Illustrate Microsoft Copilot & chatbot platform / technology with underlying OpenAI generative AI/MLLLM under the hood- also Microsoft Bing boosted (RAG-Retrieval Augmented Generation) emphasizing cautionary caveats on inherent AI/ML bias
• Extending Microsoft Copilot with proprietary enterprise data including hosted on Sharepoint Online tenant sites, utilizing Microsoft Search Full-Text search (.e.g. Smart-Search+) to fact check or verify generative response accuracy by You-the-Human !
RAM BALANI, CEO / Founder, eSTARHelper (USA)
10:00 – FDA’s Office of Criminal Investigations - Online Pharmacies and Counterfeit Drug Investigations
• Overview of FDA OCI
• Overview of a Rogue Online Pharmacy Network
• Case Examples of Online Pharmacy Network and Counterfeit Drug investigations
DEREK ROY, Resident Agent in Charge, FDA Office of Criminal Investigations
10:50 – Morning Coffee & Networking
11:20 – Transforming R&D Supply Chain and Logistics for Biopharmaceutical Industry Using an Operational Excellence Roadmap
• Challenges in applying Operational Excellence in R&D
• Developing an Operational Excellence roadmap for R&D
• Case study: Transformation of R&D Supply Chain and & Logistics using principles of Operational Excellence
VATSALA SADASIVAN, Global Operational Excellence Lead, R&D, Sanofi
11:50 – Panel Discussion with the experts – Serialization and track & trace - DSCSA compliance and 2024 implementation timeline
• DSCSA compliance and 2024 implementation timeline
• Complying With the DSCSA
• Current operational issues associated with traceability implementation
• The long-term data advantage of Track & Trace
• Technology and the future of drug traceability.
• Progress in packaging and serialization.
• When misalignment happens, what do you do?
• The road ahead for pharmaceutical track-and-trace.
Moderator
RAM BALANI, CEO / Founder, eSTARHelper (USA)
Panellists
NICOLE JOHNSON, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
AMANDA SAMOJEDNY, Vice President Operations, Amici Pharmaceuticals
JOSE CAMARA SANTIAGO, CEO, Camara Validation & Consulting Services
12:40 – SATT PLATFORM in Azure protected by Microsoft - Inside look at the development of the most secure Тrack and Тrace system
• Global track and trace compliance – ensure a swift response to market demands;
• Reduction of supply chain complexity – optimize the processes and procedures;
• Seamless integration with other hardware/software vendors;
• Data security – advanced reliability and availability directly through Azure;
• Unparalleled scalability and flexibility – enable seamless scaling of services;
• Cost-efficiency – improve operational effectiveness and maximize the investment;
• Efficient resource management – ultimately enhancing productivity.
VENELIN DIMITROV, CEO, SoftGroup
13:10 – Networking luncheon / Exhibition Visit
14:00 – Assessing Serialization Readiness and Compliance in M&A situation.
• Create awareness among the technical experts (the audience) the significance of serialization in the bigger picture; engaging in a conversation with the M&A generalist (me); opening slides from me, open up for discussion- if there is interest create a white paper out of it.
• Pay top dollars to buy, can lose the business quickly if shipment to customers is at risk, any factors that put this at risk, last few years Serialization has been the elephant in the room
• Two parts of the processes - Diligence pre buying / Integration post buying
• Either situation assess, factor in Serialization – infrastructure, quality of documentation, processes, people from a seamless business continuity perspective in - Own Plants / Partner Plants
• INTEGRATION - Switch or not to switch packaging lines
• Serialization Workstream how it would fit into the other Integration workstreams.
• Executing, seamless to the customer.
RAHUL SAIKIA, Head of M&A, Chief Strategy Officer, Rising Pharmaceuticals
14:30 – Topic TBC
TODD BOYETT, Chemical Investigations Section, Diversion Control Division, Drug Enforcement Administration (DEA)
15:00 – Panel Discussion: Regulatory Perspective-Recent DSCSA updates and Global developments
• Organisations and agencies work together and its importance / maintaining visibility and transparency
• Recent evolving regulatory frameworks towards counterfeit drugs
• Most recent track and trace regulations
• Online counterfeits – working together with the regulators to overcome this issue
• Update – Enforcement policies and guidelines
• Role of the Pharmaceutical Companies / Regulators
• What’s the way forward?
Moderator
RAM BALANI, CEO / Founder, eSTARHelper (USA)
Panellists
CEM AYDIN, Associate Director - Team Lead Logistics and Warehouse, MorphoSys
URIMARA ARGOTTI, Regional Regulatory Policy LATAM Head, Roche
LYNN MEHLER, Partner, Hogan Lovells
15:50 – Chairperson’s closing remarks and end of conference
16:00 – Networking Tea / Coffee & End of 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024
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• EDGYN, formerly Arjo Solutions and spin-off of former leading banknotes manufacturer Arjowiggins Security, has been active for more than 20 years in the protection of brands and products, supporting its customers, in the private or governmental sectors, in fighting against illicit trade, securing of their revenues and protecting consumers.
• EDGYN develops and industrializes highly innovative physical or digital authentication solutions and has developed a portfolio of 100+ patents.
• EDGYN is notably a pioneer in digital fingerprint solutions, enabling to authenticate products with a smartphone.
• EDGYN is active in the pharmaceutical, cosmetics, spirits, luxury, agrochemicals and automotive sectors providing security solutions to the leading players in each sector.
• EDGYN is also active in the governmental sector, providing security solutions for tax stamps, ID document or precious metals.
Visit our website: www.edgyn.com
SoftGroup is a global software company that supports the Pharmaceutical industry to achieve worldwide track and trace compliance, improving the overall business efficiency and security level of data exchange. The company provides full-stack serialization and aggregation solutions from level 1 to level 5 (from serialization and aggregation machines and software for the production line, through a centralized serialization management system, secure communication among business partners to reporting to National and International Authorities).
SoftGroup developed an advanced Track & Trace brand line built on well-established Microsoft Azure technology. Developing the future-ready traceability service SATT PLATFORM®, SoftGroup continues to go straight forward in amplifying innovative Track and Trace products to enable global regulatory compliance and overall pharma supply chain transparency.
In the last 21 years, SoftGroup received recognition as a reliable long-standing partner from its customers that are from Big Pharma Leaders with many production lines to small MAHs with no actual production.
Regarding the track and trace regulation in the USA, from the very beginning, the company has been working proactively on the implementation of interoperable systems and processes for enhanced drug distribution requirements under DSCSA.
SoftGroup is a Certified Gateway Provider of the EMVO, Trusted partner of the BgMVO, and a valuable partner of GS1. Additionally, it is an accredited solution provider and integrator of the CRPT system, Asl Belgisi, IS MPT, and Tatmeen.
Visit our website: www.softgroup.eu
Covectra provides complete serialization, track & trace, and authentication technologies to secure, trace and manage products across the entire supply chain, extending to the unit dose level. Transforming supply chains with end unit traceability from the packaging line to the cloud, we enable customers to ensure brand protection, product safety, supply chain integrity, and compliance in the pharmaceutical, animal health, food & beverage, and consumer products industries.
Covectra’s AuthentiTrack Cloud is a DSCSA-compliant & GS1 EPCIS-certified serialization solution capable of serial number generation, management, and aggregation from the unit dose up to pallet, with rework capability in the supply chain. AuthentiTrack Gateway handles the messaging format requirements for serialization communication across different connection partners.
Covectra’s ATLAS is a packaging line solution (Levels 1-3) designed to make it easier for manufacturers to meet compliance needs, maximize uptime, and ensure product integrity. ATLAS Enterprise is ideal for companies with multiple lines in their facility. It encompasses the site, line, packaging units to provide a complete serialization operation at the plant level. ATLAS Prime is a standalone control solution for a manufacturer with a single packaging line, making it a great fit for smaller manufacturers.
With over 4 billion serial numbers issued worldwide, Covectra is a single-source serialization provider that helps combat counterfeiting & product diversion, facilitate product recalls, and ensure compliance for global pharmaceutical brand owners.
Visit our website: www.covectra.com
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