9th Annual Pharma Anti-Counterfeiting & Serialisation 2021
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Event Speakers
NICHOLAS CALL
FDA
NICHOLAS CALL
FDA
NICHOLAS CALL, Special Agent / Senior Operations Manager, Office of Criminal Investigations, FDA
RORY CORCORAN
Interpol
SAI MUNGARA
Sun Pharma (USA)
SAI MUNGARA
Sun Pharma (USA)
SAI MUNGARA, Vice President and Head of North America Supply Chain, Sun Pharma (USA)
FILIPPO DAL M
GSK
MARCEL DE G
Abbott
SEBASTIEN M
Ferring Pharmaceuticals
SEBASTIEN M
Ferring Pharmaceuticals
SEBASTIEN MAUEL, Head of Serialization and Product Security, Ferring Pharmaceuticals
EIKE HILLBRICHT
Boehringer Ingelheim
EIKE HILLBRICHT
Boehringer Ingelheim
EIKE HILLBRICHT, Corporate Security Manager, Boehringer Ingelheim
ADRIAN VAN DH
Medicines for Europe
JEREMY PETERS
Bristol-Myers Squibb (USA)
JEREMY PETERS
Bristol-Myers Squibb (USA)
ADRIAN VAN DEN HOVEN, Director General, Medicines for Europe
MIKE ISLES
Access to Safe Medicines
PRABIR DAS
Mylan Laboratories
PRABIR DAS
Mylan Laboratories
PRABIR DAS, Head - Packaging Tech Services, OSD, Mylan Laboratories
I am one of the first batch PG alumni (1985 – 87) from Indian Institute of Packaging, Mumbai.
I have over 30 years’ experience in Pharmaceutical Packaging, with exposure in development,
execution and post commercialisation life cycle management. Major activity includes Technology
Transfer, New Product-Pack Launch, Packaging Validation, Change Management, Quality & COGS
Improvement, Automation, Standardization & Harmonization Projects, Track & Trace Project and
any kind of Innovative Packaging Development Project related to patience safety and compliance.
SULTAN DAJANI
Wainwrights Chemists
HEIKO TREFZGER
Roche
HEIKO TREFZGER
Roche
HEIKO TREFZGER, Product Manager, Business Analyst, Innovation, Representative, Roche
Heiko Trefzger, born in 1975, studied business administration with a focus on business informatics. He has almost 25 years of experience in business-IT interfacing functions in chemical and pharmaceutical industries. He is a proven expert in methods and processes in business analysis and solution management. For more than 16 years he has been working at F. Hofmann-La Roche as a business data processing specialist and business solution manager and has managed numerous strategic and business-critical projects in a global environment. As a product manager for artworks and anti-counterfeiting, he has acquired extensive know-how within the supply chain and manufacturing. He has received several awards for his activities and projects, including a “CIO Award”, the “Business Process Excellence Award” and, ultimately, for “Distinguished Team Performance” as part of an in-house innovation competition. From 2013 to 2016 he also headed a global Business Solution Manager Forum with over 80 members, successfully introducing standards for methods and processes for business analysis and portfolio management. Heiko Trefzger also lectures at the Cooperative State University in Lörrach.
DAVID WORTLEY
ISDM
KASPER ERNEST
Affordable Medicines Europe
KASPER ERNEST
Affordable Medicines Europe
KASPER ERNEST, Secretary Generalm, Affordable Medicines Europe
Kasper Ernest has worked for the last 11 years in European affairs in Brussels. Since 2018, he has been the Secretary-General of Affordable Medicines Europe. From 2009-2018 he was with the Confederation of Danish Enterprise, since 2015 serving as Director of the EU & International Department. He has also served as the Board Member of several EU-level business organisations, as a Member of the Danish Government’s Implementation Council, and was co-founder of the European Business Services Alliance. He holds a master’s degree in International Business and Politics from Copenhagen Business School and Singapore Management University. He is a guest lecturer at Copenhagen Business School.
GEORGES FRANCE
Individual Consultant
GEORGES FRANCE
Individual Consultant
GEORGES FRANCE, Individual Consultant (Former VP Global LOC Quality Lead, GSK)
PETER PITTS
Center for Medicine in the Public Interest
PETER PITTS
Center for Medicine in the Public Interest
PETER PITTS, President & Co-founder, Center for Medicine in the Public Interest (Former FDA’s Associate Commissioner for External Relations)
MERIEM LOUDIYI
Servier
MERIEM LOUDIYI
Servier
MERIEM LOUDIYI, Head of Unit – IP Legal Counsel, Trademarks & Fight against Falsification Dept, Servier
“Competences to Combat Counterfeits”
Event Schedule
Meet and to network with your conference colleagues.
09:30 – Welcome Address & Virtual Conference Platform Instructions
09:40 – Benefits beyond the EU Falsified Medicines Directive - The hospital setting
• What have been the impacts of the EU FMD on hospitals and what are they doing to minimise these
• Where do benefits exist across the hospital supply chain, leveraging the new barcodes
• What uses cases are being leveraged today and will take place in future
GRANT COURTNEY, Founder & CEO, Smarter and Safer Products
10:20 – Getting Ready For The Healthcare Digitalization Wave
• Understanding the challenges
• How to prepare and stay in control
• Looking beyond digitalization
LEANDRO OLIVEIRA, Founder & Managing Director, WeDigit
11:00 – Morning Coffee & Networking
CHALLENGES & OPPORTUNITIES
11:20 – Keynote Panel Discussion – Challenges and Opportunities - To combat counterfeit drugs & other pharma supply chain threats -
• Most common ways where drugs are counterfeited – Where should a company’s focus point be regarding this? How to handle it?
• Utilize social media and educate the consumer to identify counterfeit drugs
• Stratergising your solutions based on the facts where consumers fall as victims to counterfeiters
• Next-generation anti-counterfeiting – How to prepare for it? What should be done?
• Market analysis and what to learn from other countries?
• Take advantage of new technologies
Moderator
GRANT COURTNEY, Founder & CEO, Smarter and Safer Products
Panelists
ADRIAN VAN DEN HOVEN, Director General, Medicines for Europe
EDMUND DARVIEU, VP Corporate Security, Sanofi
RAVI KALYANARAMAN, Director, Bristol-Myers Squibb (USA)
KASPER ERNEST, Secretary General, Affordable Medicines Europ
MERIEM LOUDIYI, Head of Unit – IP Legal Counsel, Trademarks & Fight against Falsification Dept, Servier
12:10 – Counteracting Counterfeiting: Post Brexit
• What is Pharma-Crime?
• The Dangers of pharmaceutical counterfeiting
• The fallout from Brexit
• Becoming Brexit proof
SULTAN DAJANI, Pharmacist Superintendent, Wainwrights Chemists
12:50 –Networking luncheon / Exhibition Visitm
FIGHTING FAKES – BRAND PROTECTION
13:50 - Establishing a reliable internal network for investigations on crime against products
EIKE HILLBRICHT, Corporate Security Manager, Boehringer Ingelheim
14:30 – The Art of Anti-Counterfeiting
HEIKO TREFZGER, Product Manager, Business Analyst, Innovation Representative, Roche
15:10 – Afternoon coffee & Networking
DIGITAL MEDICINE
15:30 – The Future of Digital Medicine – Challenges and Opportunities for the Pharma Sector
• The rise of digital therapeutics as an alternative to drugs
• Clinical validation of digital medicine
• Digital Medicine opportunities for Pharmaceutical companies
• Anti-counterfeiting technologies for digital medicine
DAVID WORTLEY, Vice President, International Society of Digital Medicine (ISDM
16:10 – How Covid Pandemic is changing the worldwide serialization&traceability environment
FILIPPO DAL MASO, Head of Anticounterfeiting Serialization Programme, GSK
16:50 - End of conference Day One
FIGHT AGAINST FAKE
09:40 – ‘INTERPOL’s fight against Pharmaceutical Crime during the pandemic and onwards’
RORY CORCORAN, A/Assistant Director, Organized and Emerging Crime, Interpol
10:20 – The Rise of Falsified Medical Products during the COVID-19 Pandemic and upstream Internet solutions
• Rogue Internet pharmacies capitalising on misinformation and fear – viral marketing with social media trends and
illegally operating websites
• How governments are responding
• The potential impact of the new EU Digital Services Act and how domain name accountability should be a top priority
• Other important silver bullets to address the increasing availability of falsified medical products on the Internet
MIKE ISLES, Executive Director, European Alliance for Access to Safe Medicine
11:00 – Morning Coffee & Networking
11:20 – “Fighting the Fakes”: where are we in the global battle against falsified medicines?
• Serialisation and the Falsified Medicines Directive – reducing the risk of counterfeiting through unique identification
• GS1 standards from manufacture to supply – where GS1 standards help to close the gap on supply chain vulnerabilities
• The human cost of counterfeiting – the implications for patient safety and how to overcome them in clinical settings
GLEN HODGSON, Head of Healthcare, GS1 UK
MARKET ANALYSIS & CURRENT OVERVIEW
12:00 – FDA OCI enforcement initiatives during COVID-19
NICHOLAS CALL, Special Agent / Senior Operations Manager, Office of Criminal Investigations, FDA
12:40 – Networking luncheon / Exhibition Visit
13:40 – Technology Contribution Smart Packaging & Labelling
PRABIR DAS, A postgraduate from Indian Institute of Packaging (1985-’87)
SERIALISATION – TRACK & TRACE
14:20 – Panel Discussion with the experts– Next steps for serialisation in the pharma supply chain
• Managing the transformation
• Gaining value from Serialization: Efficient internal operations
• Practical approach to implementing a serialisation solution – Challenges and Solutions
• Future market trends
• Track & Trace – The smart solution
• What are the traceability challenges still to overcome in the next 5 years?
• Reduce your serialization costs
• Viewing serialisation as an opportunity – Business and Supply chain optimisation
Moderator
GRANT COURTNEY, Founder & CEO, Smarter and Safer Products
Panelists
SAI MUNGARA, Vice President and Head of North America Supply Chain, Sun Pharma (USA)
SEBASTIEN MAUEL, Head of Serialization and Product Security, Ferring Pharmaceuticals
MARCEL DE GRUTTER, Liaison Regulatory & Government Affairs, Abbott
PATRIK MERCKELL, External Business Process Analyst and Project Manager, Roche
15:10 – Afternoon coffee & Networking
MAXIMISING SUPPLY CHAIN SECURITY
15:30 – “Pharmaceutical Forensics: Applying state of the art spectroscopic technologies to ensure the security and safety of our Patients.”
• Scope of the counterfeiting issue – Why apply state of the art technologies?
• Current State – How we are, and have, applied technologies to fight counterfeiting and protect patients?
• Future State – Vision for how (and what) new technologies could be utilized to ensure business and patient security
JEREMY PETERS, Scientist, Bristol-Myers Squibb (USA)
REGULATORY
16:10 – Panel Discussion: Regulatory Perspective - Global developments & updates
• Recent evolving regulatory frameworks
• A regulatory perspective towards counterfeit medicines – what is the global answer to this global plague?
• Work with regulatory agencies, industry organizations, international agencies
• What governments expect from brand holders and pharmaceutical stakeholders?
Moderator
GRANT COURTNEYm, Founder & CEO, Smarter and Safer Products
Panelists
ROBERT POPOVIAN, CEO, Conquest Advisors (Former VP, Gov Relations, Pfizer)
LINCOLN TSANG, Partner, Arnold & Porter
PETER PITTS, President & Co-founder, Center for Medicine in the Public Interest (Former FDA’s Associate Commissioner for External Relations)
GEORGES FRANCE, Individual Consultant (Former VP Global LOC Quality Lead, GSK)
WAYNE WINEGARDEN, Sr Fellow & Director Center for Medical Economics & Innovation, Pacific Research Institute
17:00 - End of 9th Annual Pharma Anti-Counterfeiting & Serialisation 2021
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Food And Drugs Authority, Ghana Head, Market Surveillance Unit
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Bayer Consumer Care AG Head Global Packaging Management
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