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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.
FDA
FDA
DEREK ROY, Resident Agent in Charge, FDA Office of Criminal Investigations
HSI
HSI
BRIAN ANDERSEN, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
DEA
DEA
TODD BOYETT, Chemical Investigations Section, Diversion Control Division, Drug Enforcement Administration (DEA)
Special Agent Todd Boyett has been with the Drug Enforcement Administration within the United States Department of Justice since 2005. His previous assignments included the Los Angeles Field Division where he served on the Clandestine Laboratory Enforcement Team, the Cartel Strike Force and was a Group Supervisor for five years.
For the past three years, SA Boyett has served as a Staff Coordinator in the Chemical Investigations Section, Office of Diversion Control. This section consists of experts in the field of precursor chemical and pharmaceutical manufacturing equipment control who assist with operational, regulatory, legal and legislative matters in DEA’s ongoing efforts to monitor and regulate these markets.
Bristol-Myers Squibb
Bristol-Myers Squibb
SCOTT HUFFMAN, Associate Director, Forensics & Innovative Technologies, Bristol – Myers Squibb
Sanofi
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.
eSTARHelper (USA)
eSTARHelper (USA)
RAM BALANI, CEO / Founder, eSTARHelper (USA)
Ferring Pharmaceuticals
Ferring Pharmaceuticals
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
SICPA Securink
SICPA Securink
NEIL IVEY, VP, Authentication Solutions, SICPA Securink
Sanofi
Sanofi
VATSALA SADASIVAN, Global Operational Excellence Lead, R&D, Sanofi
MorphoSys
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.
Sanofi
Sanofi
OPEYEMI ODUSAMI, Former Associate Director, Global Supply Chain Product Lead, Sanofi
Systech
Systech
ADAM BARTLETT, Solutions Consultant Manager, Systech
Systech
Systech
JACK DOWNEY, Solutions Architect Manager, Systech
Rising Pharmaceuticals
Rising Pharmaceuticals
RAHUL SAIKIA, CSO, Rising Pharmaceuticals
Cambridge Pharma
Cambridge Pharma
ASMITA KHANOLKAR, Sr. Director, Medical Device, Cambridge Pharma
Partnership for Safe Medicines
Partnership for Safe Medicines
SHABBIR IMBER SAFDAR, Executive Director, Partnership for Safe Medicines
AlpVision SA
AlpVision SA
LAUREN MOISE, US Head of Sales, Marketing, and Operations, AlpVision SA
SoftGroup
SoftGroup
VENELIN DIMITROV, CEO, SoftGroup
• Venelin Dimitrov is the Founder & Chief Executive Officer of SoftGroup. Venelin’s leadership has helped establish SoftGroup as a reliable technology partner that delivers traceability technology for the pharmaceutical industry worldwide.
• His IT voyage began more than 20 years ago and determines his in-depth technical knowledge in software engineering. Mr. Dimitrov holds a Master’s Degree in Computer Science.
• Considering himself to have been a convergent thinker from an early age, he is a passionate technophile and highly experienced entrepreneur.
• His craftsmanship in setting the right direction and his excellent business savvy are the main pillars that helped him to establish SoftGroup as a reliable technology partner that delivers traceability technology worldwide.
Black Diamond Networks
Black Diamond Networks
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
CVCS
CVCS
JOSE CAMARA SANTIAGO, CEO, Camara Validation & Consulting Services
Biomedical Enterprises
Biomedical Enterprises
GLENN TAMIR, President, Biomedical Enterprises
EDGYN
EDGYN
CAMILLE DISS, CPO, EDGYN
Camille has started as the project manager, deploying fingerprint technology into major groups and governments since 2012.
From these 10 years of experience Camille has developed brand protection, technologies, and operations knowledges that has bring her to a position of CPO & Sales / Marketing Director of EDGYN.
Axia Institute, MSU
Axia Institute, MSU
BAHAR ALIAKBARIAN, Sr. Director, R&D, Axia Institute, Michigan State University
• Dr. Aliakbarian is the Senior Director of Research & Development at the Axia Institute and an Associate Professor in the Department of Biosystems and Agricultural Engineering at Michigan State University. She completed her Ph.D. in Chemical, Process, and Material Engineering from the School of Innovative Sciences and Technologies at the University of Genoa (Italy) in 2009. Before joining MSU in 2017, she held positions at the University of Genoa, Harvard-MIT Health Sciences & Technology, and the University of Sydney.
• Bahar has received numerous prestigious awards and fellowships, including the AIM Tedd William Award, the MSU Academy for Global Engagement Fellowship, the MTRAC AgBio Innovation Award, the Italian Scientific Qualification Award, the European Social Fund in Liguria Region for Postdoctoral Research Award, and the Australian Endeavour Research Award.
• Dr. Aliakbarian leads a multidisciplinary team focused on using engineering and smart technologies to enhance food and pharmaceutical supply chain security and sustainability. She manages the Axia RFID Lab, one of the first labs worldwide pioneering research on RFID applications in business sectors such as healthcare, food and agriculture, and advanced manufacturing.
• Bahar actively contributes to shaping the future of RFID in healthcare, serving as an Ad Hoc member of the GS1 Healthcare US Executive Leadership Committee and a member of the RAIN Alliance Healthcare Workgroup, among other roles. She is also a sought-after speaker at industry and academic events, with a prolific body of work that includes over 90 peer-reviewed articles, four book chapters, and four patents.
Ten Count Consulting
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
Sidley Austin
Sidley Austin
NATE KREVOR, Managing Associate, Sidley Austin
NATE KREVOR is a managing associate in the Food, Drug and Medical Device group at Sidley Austin LLP. He advises pharmaceutical and medical device companies, such as manufacturers, repackagers/relabelers, distributors, and dispensers, in various litigation, enforcement and regulatory matters on the Food, Drug and Cosmetic Act, including internal investigations and regulatory inspections.
As part of his supply chain practice, Nate assists companies with application of the Drug Supply Chain Security Act and advises on issues and incidents related to counterfeit, diverted, stolen, adulterated, and misbranded product. Prior to law school, Nate worked for a pharmaceutical manufacturer in the San Francisco Bay Area.
Meet and to network with your conference colleagues.
26th June
27th June
JACK DOWNEY
08:00 – Coffee and registration
JACK DOWNEY
08:50 – Morning Chair’s opening remarks
RAM BALANI, CEO / Founder, eSTARHelper (USA)
JACK DOWNEY
09:00 – 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
JACK DOWNEY
09:40 – 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
JACK DOWNEY
10:10 – Pinpointing Vulnerabilities: Identifying Counterfeit Entry and Diversion Points in the Pharma Supply Chain
• Comprehensive examination of the pharmaceutical product lifecycle, identifying critical junctures prone to counterfeiting and diversion, supported by recent cases.
• Practical guidance on integrating innovative technologies, such as AI-driven analytics and product fingerprinting techniques, into supply chain operations to prevent these risks.
• Examples of successful implementation of these technologies and potential future strategies from the latest research.
LAUREN MOISE, US Head of Sales, Marketing, and Operations, AlpVision SA
JACK DOWNEY
10:40 – Morning Coffee & Networking
JACK DOWNEY
11:10 – 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
NEIL IVEY, VP, Authentication Solutions, SICPA Securink
BEN LOCWIN, Vice President, Project Solutions, Black Diamond Networks
NATE KREVOR, Managing Associate, Sidley Austin
JACK DOWNEY
12:00 – “Uncovering vulnerabilities: Five steps to secure your supply chain”
• Proactive protection starts with knowing your supply chain.
• Greatest threat is not what can be seen, but what cannot be seen.
• Identifying supply chain vulnerabilities and associated risks is key to mitigation
• A multi-prong approach gets best results
ADAM BARTLETT, Solutions Consultant Manager, Systech
JACK DOWNEY
12:30 – “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
JACK DOWNEY
13:00 – Networking luncheon / Exhibition Visit
JACK DOWNEY
14:00 – 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
JACK DOWNEY
14:30 – Unveiling the Expertise: Combating Parallel Markets
• Role of Serialization and Traceability: Exploring the performance and potential improvements.
• Invisible or Visible Protection? Analyzing the effectiveness of different protection mechanisms.
• Anti diversion : Reliable Authentication solution ?
• Parallel Markets vs. Black Markets: Investigating their relationship and impact.
CAMILLE DISS, CPO, Business Development and Marketing Manager, EDGYN
JACK DOWNEY
15:00 – Afternoon coffee & Networking
JACK DOWNEY
15:30 – 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
CHIRAG SHAH, Director of Supply Chain Security, Sanofi
ASMITA KHANOLKAR, Sr. Director, Medical Device, Cambridge Pharma
NEIL IVEY, VP, Authentication Solutions, SICPA Securink
OPEYEMI ODUSAMI, Former Associate Director, Global Supply Chain Product Lead, Sanofi
JACK DOWNEY
16:20 – 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
JACK DOWNEY
16:50 – Chairperson’s closing remarks
JACK DOWNEY
17:00 – 18:00 – Networking Drinks Session
JACK DOWNEY
08:00 – Coffee and registration
JACK DOWNEY
08:50 – Morning Chair’s opening remarks
RAM BALANI, CEO / Founder, eSTARHelper (USA)
JACK DOWNEY
09:00 – “Securing a Resilient Supply Chain Through Dynamic Partnerships – Introduction to the Intellectual Property Rights Coordination Center”
BRIAN ANDERSEN, Special Agent / National Program Manager, Homeland Security Investigations (HSI)
JACK DOWNEY
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)
JACK DOWNEY
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
JACK DOWNEY
10:50 – Morning Coffee & Networking
JACK DOWNEY
11:20 – Product Authentication in a Counterfeit World
• Advanced technologies and the ease of knowledge transfer has fostered a more difficult environment for authentication solution providers and users.
• Effective solutions need consumer engagement and participation in the authentication process, requiring easy to recognize yet hard to replicate tamper-evident or destructive overt features, along with covert or forensic features known only to your company.
• Ease of implementation into the existing supply chain and manufacturing process is possible with even the most advanced solutions.
NEIL IVEY, VP, Authentication Solutions, SICPA Securink
JACK DOWNEY
11:40 – 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
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
JOSE CAMARA SANTIAGO, CEO, Camara Validation & Consulting Services
JACK DOWNEY, Solutions Architect Manager, Systech
GLENN TAMIR, President, Biomedical Enterprises
JACK DOWNEY
12:30 – 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
JACK DOWNEY
13:00 – Networking luncheon / Exhibition Visit
JACK DOWNEY
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
JACK DOWNEY
14:30 – Drug Enforcement Administration – Diversion Control Operations
TODD BOYETT, Chemical Investigations Section, Diversion Control Division, Drug Enforcement Administration (DEA)
JACK DOWNEY
15:00 – Use of Smart Technologies to Improve Track and Trace of Pharmaceuticals
• An overview of the Axia Institute Smart Research Platform
• RFID as an enabler of pharmaceutical traceability required by DSCSA
• RFID and NFC as enablers of anti-counterfeit and medication adherence
BAHAR ALIAKBARIAN, Sr. Director, R&D, Axia Institute, Michigan State University
JACK DOWNEY
15:30 – 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
BAHAR ALIAKBARIAN, Sr. Director, R&D, Axia Institute, Michigan State University
JACK DOWNEY
16:10 – Chairperson’s closing remarks and end of conference
JACK DOWNEY
16:15 – Networking Tea / Coffee & End of 14th Annual Pharma Anti-Counterfeiting, Serialisation & Supply Chain Security 2024
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We wouldn’t be able to host our conferences without help from these amazing companies.
A huge thanks to all our sponsors and partners!
Systech delivers digital identification and traceability solutions that establish essential product data, ensure digital connectivity, and enable real-time insights on the packaging line and throughout the supply chain. With decades of experience in pharmaceutical packaging execution and serialization, Systech offers comprehensive, easily configured, turnkey software solutions with reliable implementation and expert support.
Global brands across industries rely on Systech’s platform to help them achieve their objectives in compliance, resiliency, sustainability, and digital transformation. Systech is a leading brand of Markem-Imaje®, a global product identification, packaging intelligence and connected product solutions provider.
Visit our website: www.systechone.com
Our mission is to develop and deploy innovative, scalable and secured brand protection solutions to support our clients in fighting against illicit trade, in improving transparency, integrity and trust in their supply chain and products and protecting their customers against counterfeiting. Following the acquisition of Signoptic in 2012, we have been developing and deploying the most advanced solutions in digital authentication, based on our unique expertise and proprietary technology in digital fingerprint and product biometry.
Our digital fingerprint solution, Signoptic®, was first industrialized in 2008. We have continuously invested and invented to keep it at the forefront in the fight against illicit trade, applying it to new products and releasing in 2019 an smartphone version of the solution, Adfirmia™.
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
Since its inception in 2001, AlpVision has been at the forefront of authentication technology, becoming a crucial partner for numerous Fortune 500 companies. AlpVision’s innovative and cost-effective solutions protect over 30 billion branded products annually across various industries. AlpVision is consistently recognized by market research firms as a key player in the anti-counterfeiting market and was accredited by the LBMA in 2023 as the market standard for gold bar authentication.
Their proprietary technologies, AlpVision Fingerprint® and Cryptoglyph®, are invisible yet detectable via smartphone apps. AlpVision Fingerprint® allows the authentication of entire product lines using a single reference image, while Cryptoglyph® is applied during routine printing processes to the varnish layer, solid color areas, or QR codes. Both technologies feature a server-based web application for real-time monitoring, customizable and integrable with existing systems, providing businesses with valuable insights into their product lifecycle.
Achieving profitability by 2003, AlpVision has expanded its presence globally, with headquarters in Switzerland and offices in China and the US. AlpVision serves diverse industries, including pharmaceuticals, precious metals, and automotive lubricants. Their adaptable solutions ensure brand and customer confidence, safeguarding products from counterfeiting and gray market activity. For more information, visit AlpVision.
Visit our website: www.alpvision.com
SICPA is a leading global provider of secured authentication, identification, and traceability solutions and services. With over 90 years of experience, our solutions are found in over 90% of the World’s currency, on pharmaceutical packaging, in passports and a wide range of other products and value documents. SICPA’s range of proven and patented overt, covert, and forensic authentication solutions are designed to seamlessly integrate into your existing manufacturing and packaging processes.
Our overt, cost-effective, and easily recognizable QUAZAR® solution protects billions of dollars of pharmaceutical products, can be partnered with our anti-copy secure QR code solution, REVEO®, and be a carrier for covert and forensic markers including SICPAGUARD®.
Visit our website: www.sicpa.com
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
TrackTraceIT is poised to make a significant impact in the serialization landscape, especially within the pharmaceutical industry where compliance with regulations like DSCSA, FMD & CRPT is crucial. Serialization and traceability are indeed becoming increasingly vital across various industries, including pharmaceuticals, food/beverage, and luxury brands, to ensure product safety, combat counterfeiting, and streamline supply chain operations. Our Digital Transformation Suite solutions offers AI & AR solutions that make us different by not only resolving the issue but also increasing the operational efficiency of the pharmaceutical manufacturing.
Our team’s extensive experience spanning various facets of serialization, from manufacturing to sales and project management, positions you well to address the challenges within the serialization ecosystem effectively. By leveraging your collective expertise, TrackTraceIT can provide comprehensive solutions to help companies navigate the complexities of implementing serialization technologies seamlessly into their production environments and supply chains.
As serialization continues to evolve and gain prominence, companies will increasingly rely on specialized expertise to ensure compliance and optimize processes. TrackTraceIT’s focus on addressing the top challenges in serialization indicates a commitment to driving innovation and efficiency in this critical area, which will likely be welcomed by industry stakeholders seeking reliable solutions.
Visit our website: www.tracktraceit.com
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4 Hours deep dive training in some topics “},{“name”:”Camara Validation & Consulting Services”,”designation”:”CEO”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
I think the event was excellent at all. Good topics selection, speakers and organization.
“,”_id”:”7a75f70″},{“name”:”Apellis Pharmaceuticals”,”designation”:”Associate Director, Package Labelling”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
It was nice to learn how US government gets involved in helping the manufacturers catch counterfeit products. Some of the presentations were very repetitive. It would keep the conference much more interesting if there is clear distinction of topics and points for each presenter.
“,”_id”:”330688a”},{“name”:”Apellis Pharmaceuticals”,”designation”:”Manager”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Great Storyline with the speakers. Everything was very relevant and interesting. Well organised
“,”_id”:”ea3e100″},{“name”:”WCO IPM”,”designation”:”Manager”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Great Storyline with the speakers. Everything was very relevant and interesting. Well organised
“,”_id”:”8c3f8b1″},{“name”:”Food And Drugs Authority, Ghana”,”designation”:”Head, Market Surveillance Unit”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”_id”:”3b8df8f”,”quote”:”
Very interactive and gave platform for information sharing, Very Interative
“},{“name”:”Element Six “,”designation”:”Business Development Manager”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”_id”:”34ab65e”,”quote”:”
Good subject knowledge from all the presenters. Good meeting room environment and refreshments
“},{“name”:”Bayer Consumer Care AG”,”designation”:”Head Global Packaging Management”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”_id”:”eb31001″,”quote”:”
Well organised. Mainly good speakers, good lunch and good venue
“},{“name”:”horus security”,”designation”:”Horus Security Consultancy”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
An interesting conference, informative on both a personal and professional basis
“,”_id”:”8ca6872″},{“name”:”Selcia ltd”,”designation”:”Business Development Director”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Very Informative - good range of topics covering regulatory, data protection and supplies of services. Excellent discussion and networking opportunities
“,”_id”:”a127a82″},{“name”:”Novartis International”,”designation”:”Product Security Analyst”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
u201cVery interesting insights, all topics covered were relevant and useful to anti-counterfeiting efforts in pharma.u201d
“,”_id”:”0583018″},{“name”:”QPQuandary”,”designation”:”CEO”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
u201cThe eclectic mix of speakers and delegates provided an excellent opportunity to build on existing knowledge and gain wider knowledge of the subject of pharmaceutical anti-counterfeiting.u201d
“,”_id”:”ca8a9eb”},{“name”:”AstraZeneca Plc”,”designation”:”Regional Investigations Director EMEA, Global Security”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
u201cThe day was well attended by a wide range of industry representatives and resulted in informative and helpful discussion.u201d
“,”_id”:”d9d5bce”},{“name”:”Food And Drugs Authority, Ghana”,”designation”:”Regulatory Officer ( Safe Disposal of Regulated Products)”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Good platform to learn about what others are doing about the menace SSFFC medical products, Very Insightful program. Given me more exposure to the global efforts at fighting fake medicines
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4 Hours deep dive training in some topics
I think the event was excellent at all. Good topics selection, speakers and organization.
It was nice to learn how US government gets involved in helping the manufacturers catch counterfeit products. Some of the presentations were very repetitive. It would keep the conference much more interesting if there is clear distinction of topics and points for each presenter.
Great Storyline with the speakers. Everything was very relevant and interesting. Well organised
Great Storyline with the speakers. Everything was very relevant and interesting. Well organised
Very interactive and gave platform for information sharing, Very Interative
Good subject knowledge from all the presenters. Good meeting room environment and refreshments
Well organised. Mainly good speakers, good lunch and good venue
An interesting conference, informative on both a personal and professional basis
Very Informative – good range of topics covering regulatory, data protection and supplies of services. Excellent discussion and networking opportunities
“Very interesting insights, all topics covered were relevant and useful to anti-counterfeiting efforts in pharma.”
“The eclectic mix of speakers and delegates provided an excellent opportunity to build on existing knowledge and gain wider knowledge of the subject of pharmaceutical anti-counterfeiting.”
“The day was well attended by a wide range of industry representatives and resulted in informative and helpful discussion.”
Good platform to learn about what others are doing about the menace SSFFC medical products, Very Insightful program. Given me more exposure to the global efforts at fighting fake medicines
The Conference Center at Waltham Woods,
Waltham (Boston-MA)
Address: 860 Winter St, Waltham, MA 02451, USA
Contact: 781.434.7499
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
Piyush Patel
piyush@virtueinsightevents.com
+44 20 3509 3779
