Temperature Controlled Logistics in Biopharmaceuticals Europe 2023

Exploring best practice: industry regulations, end-to-end transportation, digitalisation, sustainability and mitigating risks

15 - 16

March

2023
  • NH Milano Congress Centre, Italy
  • Complimentary
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Featured Speakers

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Gianpiero Lorusso​

Director, Head of Global Upstream Logistics, Supply Network Operations, Global Healthcare Operations, Merck

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Ana Martinez Lozano​

Associate Director Distribution & Logistics Quality EMEA Lead, MSD

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Guillaume Lefert​

Senior Manager Vaccines Distribution and Cold Chain, GSK

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Sonia Ben Hamida​

PhD, Head of Special Cargo Operations, Safety and Security – Cargo, IATA

As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

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Dr Kamal Amin​

Head Of Clinical Supplies Management, Galderma

Kamal is a trained Chemist who decided to pursue a career in supply chain management and quality. In this role, he was tasked to supervise commercial and clinical trial products. Kamal has worked in the pharmaceutical and device industries for over 15 years in different size organisations ranging from large multinational to small virtual companies. He is currently leading a global team at Galderma to develop an integrated clinical supply chain organisation within the company.

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Francesca Burberi​

Associate Director Six Sigma Projects, Eli Lilly

Pharmacist, with more than 30 years’ experience in biopharmaceutical manufacturing with a degree in
Chemical & Pharmaceutical Technology and competencies in Quality, Qualification, Validation, Shipping,
Technical Services and Lean Manufacturing areas. In Lilly since 1992, today in the Information Technology
division, she is responsible for managing Projects Site agenda and Lean Manufacturing/ Operational
Excellence program, after different experiences in Italy and abroad, as responsible manager of
Calibration/ Periodic Validation/ Cold Chain/ Technical Services/ Quality/ Training departments. She is
member of Pharmacomitalia Technical Committee as an expert in Cold Chain shipping and validation.
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Silvana Furfaro​

QA/RA Manager, Arrow Diagnostics

Silvana Furfaro is currently the Head of Quality Assurance and Regulatory Affairs of Arrow Diagnostics SrL placed in Genoa, Italy.

Arrow Diagnostics is the Italian subsidiary of Seegene Inc, Seoul, Rep. of Korea, a worldwide leader of In Vitro Diagnostics products in the field of Virology, Microbiology, Oncology, and Anatomy Pathology.

Arrow Diagnostics is the exclusive importer of many important foreign companies in IVD field, and this company is also manufacturer of the IVD products branded AD4SEQ with NGS technology CE-IVD marked and currently ongoing under IVDr.

Silvana Furfaro is also Person Responsible for Regulatory Compliance for the reagents manufactured under AD4SEQ brand.

The company is certified ISO9001 and ISO13485:2016 with the ON BSI Netherlands.

In 2021, Arrow Diagnostics obtained the EU 2017/746 Regulation assessment, and submitted many Technical Files for the IVDr certification, that became official law last year, at May 26th 2022.

Being member of the Technical Committee of PharmacomItalia, she has a large experience in Molecular Biology and in pharmaceutical companies (more than 33 years).

In the past, Mrs. Furfaro worked in pharmaceutical companies as Manager of Quality Control, Quality Assurance, and Manufacturing Departments, improving her knowledge in GMP and GDP.

Mrs. Furfaro’ s main goal is to contribute at positioning Arrow Diagnostics as one the most important Italian manufacturers in the IVD field, in the next five years

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Clément Grenier​

Clinical Supply Project Operational Leader, Sanofi

After 10 years working in the pharmaceutical transport, 6 years as a Clinical Trial Project Manager for World Courier and 4 years as a Global Cold Chain Manager for Cryopdp, Clément integrated the biopharmaceutical industry in 2019 as a Logistics Specialist for Cellectis, a pioneer biotech in the allogeneic CAR-T Cell therapies. In 2022, Clément joined Sanofi Clinical Supply Chain to implement the Cell therapy clinical programs as a Project Leader.

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Marco Del Giudice​

CEIV Auditor, Co Founder and VP, PharmacomItalia

Marco Del Giudice is the founder of the MdG Group comprehending MdG Srl., MdG Consulting and MdG Academy. MdG provides worldwide the pharma and logistic industry with products and services for the cold chain. He has been working in the logistic industry since 1995 and made his first 11 years of experience in companies like Lufthansa Cargo, Trenitalia Cargo and DHL Global Forwarding a Life Science & Healthcare Industry Country Manager. Since 2014 Marco is active for the IATA CEIV Pharma certification as independent validator with more the 95 audits world wide. In 2018 he founded and is still VP of PharmacomItalia, an Italian non-profit association which has members of the pharmaceutical and logistics industry and which deals with common issues of the transport of medicines.

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    2023 Sponsors Include:

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    Company Information

    Berlinger & Co. AG develops, produces, and distributes temperature monitoring solutions for pharmaceutical, biotechnology and research organizations. With over 30 years’ experience, our innovative site and in-transit temperature recording devices, along with our data management software, improves efficiency for excursion management and increases patient safety. Berlinger offers a fully integrated temperature monitoring solution based around our SmartView platform and temperature devices, allowing full integration with your IRT system. Swiss Innovation, R & D investment and quality are key for us to deliver customer success. Our aim is to deliver the highest quality, to stand out with our service and to create relationships with the unmistakable Berlinger style.

    Company Website

    To learn more , please visit our website - http://www.berlinger.com

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    Company Information

    IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

     

    Company Website

    To learn more , please visit our website - www.iqvia.com

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    Company Information

    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

    Company Website

    To learn more , please visit our website - https://www.almacgroup.com

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    Company Information

    Biocair has established itself as the leading Specialist Logistics provider for the life sciences and remain dedicated to this industry. We provide services and support to a wide variety of organizations from multi-national pharmaceuticals, global central laboratories and clinical manufacturing organizations supplying the clinical trial arena to niche Biotech’s and individual R&D scientists across the globe. Our people and worldwide facilities manage your logistics so that you don’t have to.

    Company Website

    To learn more , please visit our website - http://www.biocair.com/

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    Company Information

    The DHL clinical trials logistics service encompasses the key stages of the supply chain. Services include inbound receipt of bulk IMPs, storage of IMPs and lab ancillaries within state of the art GMP facilities (-160oc, -20oc, 2-8oc, 15-25oc), secondary packaging, lab kit production, transportation and management of return flows (i.e. unused medication, kits or specimens).

    Distribution to investigator sites in over 80 countries around the world is through a global depot and integrated carrier network optimized to meet trial needs.

    DHL manages clinical trials logistics through dedicated study managers and bespoke clinical trials information systems.

    Website – DHL LIFE SCIENCES & HEALTHCARE EXPERTISE

    Company Website

    To learn more , please visit our website - http://www.logistics.dhl/global-en/home/our-divisions/supply-chain/sectors-overview/life-sciences-and-healthcare/our-life-sciences-and-healthcare-expertise.html

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    Company Information

    Founded in 1986 by Alois Bischof, ELPRO is a Swiss-based, global manufacturer of innovative environmental monitoring solutions for the pharmaceutical, life science, biotech and health care industries. ELPRO does not only offer state-of-the-art data loggers but also complex monitoring systems with intelligent database solutions, and overall GxP support. Automatically generated PDFs and high data security guarantee that customers worldwide can always stay compliant. ELPRO’s data loggers measure temperatures from -200 °C..+200 °C. ELPRO’s sales and technical support offices are located in Switzerland, US, Canada, UK, Germany, the Nordics, Benelux and Singapore, with 220 employees worldwide.

    Company Website

    To learn more , please visit our website - http://www.elpro.com/

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    Company Information

    We acknowledge that your products are highly sensitive to temperature and need strictly controlled shipping solutions.

    T°Safe’s precise planning, careful risk assessment and rigorous performance ensures a high quality supply chain of API and an effective, IT-powered (iDEX) clinical trial distribution of IMP. This is key for a successful partnership with our customers.

    Company Website

    To learn more , please visit our website - http://www.tsafelogistics.com/

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    Company Information

    TSS SaaS solution is developed in accordance with global quality standards to ensure safe and sustainable drug delivery to millions of patients every day. TSS cloud services, integrated with industry leading systems and sensors, creates end to end visibility in clinical and commercial operations. TSS Clinical module, launched 2019, has shortened the time spent on temperature excursion management from days down to seconds.

    Company Website

    To learn more , please visit our website - http://www.tss.se/

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    Company Information

    Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

    Company Website

    To learn more , please visit our website - www.yourway.com

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    Company Information

    Acnos Pharma is privately-owned, specialized pharmaceutical company operating globally in the clinical trial supply landscape. The headquarter is in Germany, Aachen. We offer flexible, cost efficient and quality sensitive customized solutions for individual trial requirements. We offer a broad range of clinical trial services supply chain management, clinical trial procurement and logistics.

    Th combination of passion and expertise leverages our global reach and maximizes customer satisfaction.

    Company Website

    To learn more , please visit our website - http://acnospharma.de/

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    Company Information

    Alcura is a patient-focused service with brand +20 years’ experience, delivering end-to-end bespoke solutions to support global Clinical Trials from the pre-Clinical to the Observational phase. A single point of contact, integrated IT solutions and a full range of product types and therapies are key aspects within Alcura’s service.

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    Company Website

    To learn more , please visit our website - http://www.bappharma.com/

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    Company Information

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    Company Website

    To learn more , please visit our website - http://www.bionicalemas.com

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    Company Information

    BMclinical, your global clinical trial supply partner. We offer worldwide commercial medicine supply, from analytical samples to bulk comparators, through to the supply of co-meds and pre-meds.  We can pack and label your IMP/commercial medicines from our GMP facility, where we also offer storage and distribution services. BMclinical is uniquely positioned to offer solutions for overage and unused clinical trial stock.

    Company Website

    To learn more , please visit our website - https://www.bmclinical.com

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    Company Information

    Brocacef operates throughout the entire pharmaceutical chain, lending us an unique position as a wholesaler in the Dutch pharmaceutical healthcare industry. With expertise in global logistics, sourcing and supply chain experience Brocacef is able to offer a variety of services for clinical trials.

    Company Website

    To learn more , please visit our website - www.brocacef.nl

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    Company Information

    Catalent solves today’s clinical trial challenges and develop innovative solutions for the future. Catalent’s commitment to quality and service excellence is evident in its flexible solutions, modern global facilities, and over 25 years’ experience reliably supplying thousands of studies of all sizes and complexities around the world.

    Company Website

    To learn more , please visit our website - http://www.catalent.com/index.php

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    Company Information

    Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

    Company Website

    To learn more , please visit our website - www.clinigencsm.com

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    Company Information

    Cold Chain Technologies (CCT) is an industry recognized technical leader in the development and delivery of single-use and reusable insulated thermal packaging solutions that protect the integrity of temperature sensitive payloads. With over 50 years of experience in the global cold chain, we fully understand its’ logistics and applications, demands, and extremes. CCT is a pioneer in the design and delivery of innovative and high-quality thermal packaging, and one of the industry’s largest cold chain solution providers.

    CCT is a leading global provider of single-use and reusable thermal packaging solutions for the distribution and transport of temperature-sensitive shipments and are distributed from multiple U.S. and International locations that include Europe, Latin America, and Asia.

    Company Website

    To learn more , please visit our website - www.coldchaintech.com

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    Company Information

    Creapharm: Pharmaceutical Contract Packaging & Logistics

    BIOSTORAGE: securing Biobanking of your precious biological samples
    Biospecimen kit assembly
    Biospecimen logistics
    Biological sample storage from ambient to -196°C
    Training, consulting & audit

    CLINICAL TRIAL SUPPLY MANAGEMENT: managing your Clinical Trial Material with agility
    Sourcing
    Clinical packaging/labeling & blinding
    Worldwide clinical distribution
    EU QP-Release

    Company Website

    To learn more , please visit our website - https://www.creapharm-pharma.com/

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    Company Website

    To learn more , please visit our website - www.deeplink-medical.com

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      Why attend?

      Arena International is delighted to announce that the Temperature Controlled Logistics in Biopharmaceuticals Europe conference is going to be held in Milan in 2023. Join us at the 19th edition of this key industry event where we will address the leading industry issues in a focused and productive setting. Delegates will gain access to real solutions to the challenges they face in cold chain and temperature-controlled logistics.

      “The biopharma industry loses approximately $35 billion annually as a result of failures in temperature-controlled logistics, according to IQVIA Institute for Human Data Science.”

      – Air Cargo News: The figure, quoted in the 2019 Biopharma Cold Chain Logistics Survey.

      This important industry event will bring together professionals in pharma, biopharma and biotech companies specialising in: cold chain, supply chain, logistics, procurement, quality assurance and temperature controlled logistics. Our distinguished speakers will tackle the most pressing industry challenges, will share cutting-edge technologies and will help you prepare for the future by addressing game-changing innovations.

      Join us for what will be an unmissable event in the industry calendar, one that will help you benchmark your strategies and be more effective in this dynamic industry.

      WHAT TO EXPECT FOR 2023?

      150+

      Attendees

      		20+

      Exhibitors

      		25+

      Speakers
      150+

      Attendees

      		20+

      Exhibitors
      25+

      Speakers

      TESTIMONIALS

      See What It's All About

      Agenda

      • 15 Mar 2023
      • 16 Mar 2023
      Expand All

      7:30 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      9 AM

      What have we really learnt from the pandemic?

      Speakers

      9:30 AM

      Cloud based temperature tracking & monitoring

      • Implementing applications and new technologies
      • Live updates to improve cold chain
      • Quality control
      • Anticipation of temperature deviations

      Speakers

      10 AM

      GMP and GDP regulations – understanding your requirements

      • Update on key regulations
      • New compliance requirements
      • Best practice on measuring KPIs to ensure compliance

      Speakers

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      IATA: Important changes in the 2023 Temperature Control Regulations (TCR)

      • What is new in the latest edition of the Temperature Control Regulations (TCR)
      • New requirements when shipping compliant temperature-sensitive products
      • Accessing up-to-date carrier and government regulations
      • Understanding regulatory packaging requirements
      • Documentation required before you ship

      Speakers

      11:45 AM

      Temperature control: Biopharma supply chain challenges data management can solve

      • Real time, bluetooth - stay connected with your deliveries in transit
      • Data management – have all information available when you need it
      • Process automation – make your temperature control solutions more efficient and
      • Connected systems API – integrate temperature control in your IT landscape
      • End-to-end visibility – join data of different distribution legs to one full picture

      Speakers

      12:15 PM

      Supply chain and cold-chain-as-a-service (CCaaS): Is outsourcing the next step for biopharmaceutical logistics?

      • Leading outsourced services for Phase III and for African clinical trials
      • Sourcing and supplies of in-house and outsourced cold chain solutions
      • Increasing warehousing activities: owned offices vs outsourced local service providers
      • Switching from a fully outsourced solution to a cold chain distribution service provider
      • Internalizing outsourced biotech activities to a partially in-house industrial biopharmaceutical process

      Speakers

      12:55 PM

      Lunch and networking

      2:30 PM

      Pharma’s frozen assets: Cold chain medicines

      • Pharma’s energy challenge
      • Pharmaceutical cold chain market definition
      • Developments in the cold chain market
      • Outlook and implications for pharma and their logistics partners

      Speakers

      3 PM

      Keynote: Upstream logistics – the what, who and how

      Speakers

      3:30 PM

      Lilly Sesto experience during pandemic period: new opportunities from complicated scenarios

      • The crisis of refrigerated shipments towards Chinese market
      • New solutions can come from classical ones: feasibility studies
      • Global for local and local for global
      • Lessons learnt: How can we face new dramatic scenarios?

      Speakers

      4 PM

      Afternoon refreshments, networking and prize draw!

      4:40 PM

      Panel discussion: Best practice strategies for regulatory compliance

      • Understanding your regulatory requirements in temperature controlled logistics
      • Ensuring product integrity in international logistics and national distribution
      • The key role associations play in developing best practice strategies for temperature controlled logistics
      • Resources available at IATA, PharmacomItalia and other key industry associations
      • How pharma companies can work with associations to ensure regulatory compliance

      Speakers

      5:25 PM

      Chairperson’s closing remarks

      Speakers

      5:40 PM

      Drinks reception sponsored by IQVIA

      8 AM

      Registration and refreshments

      9:50 AM

      Chairperson’s opening remarks

      Speakers

      10 AM

      Case study: Dealing with a sudden, unexpected and remarkable increase in demand for frozen In-Vitro Diagnostics (IVD) during the Covid-19 pandemic

      • How we overcame significant challenges working with frozen IVD products during the COVID-19 pandemic
      • Improvement of logistic activities due to the impact of increasing demand
      • Hands-on insights: Working with refrigerated containers when flight- transporting big amounts of frozen IVD products
      • Inbound and outbounds activities with frozen IVD diagnostics products

      Speakers

      10:30 AM

      Keynote interview Fireside Chat: How the cold chain industry is evolving and implications for temperature controlled logistics

      • Industry trends and developments in cold chain and temperature controlled logistics
      • The current and future regulatory landscape and the cost of compliance
      • How are emerging technologies changing supply chain and logistics functions
      • Thoughts on Cold Chain as a Service (CCaaS): Is outsourcing a viable solution?

      Speakers

      11 AM

      Morning refreshments and networking

      11:30 AM

      Panel discussion: Best practice transportation and logistics – cost efficient and reliable transportation solutions

      • Best Practice: Ensure the safe delivery of goods that require temperature control
      • Benefits of air transportation
      • Geographical challenges and shipment times
      • Reduction of time-to-market
      • Considerations you need to make when choosing service providers
      • Working with Air, Road and Sea transportation

      Speakers

      12:15 PM

      Live virtual presentation: Artificial intelligence and metaverse in pharma

      • How innovation can drive the digital transformation?
      • Could metaverse and artificial intelligence help the pharma industry?
      • How analytics can do the difference in the customer engagement

      Speakers

      12:45 PM

      Lunch, networking and prize draw!

      2:30 PM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical trial supply. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1: Selecting vendors and partners for your supply chain: key considerations
      Ilaria Rondinone, Senior Clinical Supply Lead, Chiesi Group

      ROUNDTABLE 2: Usage of internal systems for outsourced manufacturing steps
      Chiranth Hulgur, Senior Manager Clinical Supply Chain Data and Analytics, CSL Behring

      ROUNDTABLE 3: Forecasting the unexpected: How to handle unforeseen circumstances to reduce impact to clinical supply chains
      Ruth Barbero, Associate Director Global Clinical Supply Chain, Incyte

      ROUNDTABLE 4: The pros and cons of just-in-time labelling: What to consider when adopting this as a strategy
      Dr Kamal Amin, Head of Clinical Supplies Management, Galderma

      ROUNDTABLE 5: End-to-end visibility in clinical trial supply
      Ulrich Mengel, Associate Director, CTS Business Operations, CSL Behring

      ROUNDTABLE 6: Q&A session with U.S. Customs and Border Protection: Here to help with any questions you may have about how to import or export biological materials to or from the U.S.
      Sean Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

      George Amerson, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

       

      Speakers

      4 PM

      Chairperson’s closing remarks

      Speakers

      END OF CONFERENCE

      Speakers

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      Gianpiero Lorusso
      Director, Head of Global Upstream Logistics, Supply Network Operations, Global Healthcare Operations, Merck

      Session Details:

      Panel discussion: Best practice transportation and logistics – cost efficient and reliable transportation solutions

      2023-03-16, 11:30 AM

      Session Details:

      Keynote: Upstream logistics – the what, who and how

      2023-03-15, 3:00 PM

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      Dr Kamal Amin
      Head Of Clinical Supplies Management, Galderma

      Kamal is a trained Chemist who decided to pursue a career in supply chain management and quality. In this role, he was tasked to supervise commercial and clinical trial products. Kamal has worked in the pharmaceutical and device industries for over 15 years in different size organisations ranging from large multinational to small virtual companies. He is currently leading a global team at Galderma to develop an integrated clinical supply chain organisation within the company.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-03-16, 2:30 PM

      Session Details:

      Keynote interview Fireside Chat: How the cold chain industry is evolving and implications for temperature controlled logistics

      2023-03-16, 10:30 AM

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      Guillaume Lefert
      Senior Manager Vaccines Distribution and Cold Chain, GSK
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      Ana Martinez Lozano
      Associate Director Distribution & Logistics Quality EMEA Lead, MSD

      Session Details:

      GMP and GDP regulations – understanding your requirements

      2023-03-15, 10:00 AM

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      Chris Wallace
      Former Senior Vice President Supply Chain, Clover Biopharmaceuticals

      Chris has over 30 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

      Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for the last 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical. He is now a freelance consultant.

      He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world. Recently he has established the supply chain function in a biotech start up and successfully built the cross functional team to support the launch of a new vaccine.

      Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

      Session Details:

      Chairperson’s closing remarks

      2023-03-15, 5:25 PM

      Session Details:

      Keynote interview Fireside Chat: How the cold chain industry is evolving and implications for temperature controlled logistics

      2023-03-16, 10:30 AM

      Session Details:

      Chairperson’s opening remarks

      2023-03-15, 8:50 AM

      Session Details:

      What have we really learnt from the pandemic?

      2023-03-15, 9:00 AM

      Session Details:

      Chairperson’s opening remarks

      2023-03-16, 9:50 AM

      Session Details:

      Chairperson’s closing remarks

      2023-03-16, 4:00 PM

      Session Details:

      Panel discussion: Outsourcing storage and distribution of your temperature sensitive products

      2023-03-16, 12:30 PM

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      Sonia Ben Hamida, PhD
      PhD, Head of Special Cargo Operations, Safety and Security – Cargo, IATA

      As Head of Special Cargo at the International Air Transport Association (IATA), Dr Sonia Ben Hamida leads the development of the special cargo agenda, delivering standards, business processes, and solutions for the air cargo supply chain related to the transport of live animals, perishables, and temperature-sensitive cargo, and all other special cargo. Prior to joining IATA, Sonia held several roles in France where she spent 8 years driving innovation in the aerospace industry. Then she joined academia in 2019 as a lecturer and researcher at EPFL, the Swiss Federal Institute of Technology in Lausanne, and UNIGE, the University of Geneva. Over the past 12 years, I have built a strong expertise in project management, innovation, design, and business and systems modeling. Sonia holds an engineering degree in Aviation and Computer Science from the French Civil Aviation University - ENAC (France) and a PhD in Innovation from CentraleSupélec (France).

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      Stefania Alvino
      Head of Digital Innovation, Daiichi Sankyo

      Stefania is a Digital Orchestrator and Omnichannel Marketing Manager in Daiichi Sankyo Italy, also driver of the  Digital Transformation at European level for the country. She established strong digital marketing, social media and digital strategy experience. In her role, Stefania has developed her ability to translate theory into action in the context of change control and mind process.

      At Daiichi Sankyo Italy, Stefania is responsible for digital & omni-channel strategy, the planning of local and regional initiatives, evaluating the impact of multi-channel marketing and digital strategy to the integration of on-and offline services and initiatives to open up cross-functional opportunities.

      She has gain several awards for innovative projects in the digital and multichannel field and has been a guest speaker at various Italian and international conferences.

      Stefania has over 10 years of pharmaceutical, marketing, communications and digital experience in different company.

      She is also a journalist with several experience in radio, TV and magazines publishing several articles and nowadays she writes articles on innovation and digital transformation topics.

      Session Details:

      Live virtual presentation: Artificial intelligence and metaverse in pharma

      2023-03-16, 12:15 PM

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      Francesca Burberi
      Associate Director Six Sigma Projects, Eli Lilly
      Pharmacist, with more than 30 years’ experience in biopharmaceutical manufacturing with a degree in
      Chemical & Pharmaceutical Technology and competencies in Quality, Qualification, Validation, Shipping,
      Technical Services and Lean Manufacturing areas. In Lilly since 1992, today in the Information Technology
      division, she is responsible for managing Projects Site agenda and Lean Manufacturing/ Operational
      Excellence program, after different experiences in Italy and abroad, as responsible manager of
      Calibration/ Periodic Validation/ Cold Chain/ Technical Services/ Quality/ Training departments. She is
      member of Pharmacomitalia Technical Committee as an expert in Cold Chain shipping and validation.

      Session Details:

      Panel discussion: Best practice strategies for regulatory compliance

      2023-03-15, 4:40 PM

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      Gerardo De Pasquale
      Sr. Associate-TSMS Logistic, TS/MS Packaging & Device, Eli Lilly

      Aerospace engineer, I worked in Lilly Italia from 2011 passing from project engineering to process engineering and finally landing in logistic world. Expert in the design/qualification and maintenance of controlled temperature equipment (shipment containers, warehouses, freezers and so on) , formulation and filling of parenteral products and aseptic processes.

      Session Details:

      Lilly Sesto experience during pandemic period: new opportunities from complicated scenarios

      2023-03-15, 3:30 PM

      Session Details:

      Panel discussion: Outsourcing storage and distribution of your temperature sensitive products

      2023-03-16, 12:30 PM

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      Silvana Furfaro
      QA/RA Manager, Arrow Diagnostics

      Silvana Furfaro is currently the Head of Quality Assurance and Regulatory Affairs of Arrow Diagnostics SrL placed in Genoa, Italy.

      Arrow Diagnostics is the Italian subsidiary of Seegene Inc, Seoul, Rep. of Korea, a worldwide leader of In Vitro Diagnostics products in the field of Virology, Microbiology, Oncology, and Anatomy Pathology.

      Arrow Diagnostics is the exclusive importer of many important foreign companies in IVD field, and this company is also manufacturer of the IVD products branded AD4SEQ with NGS technology CE-IVD marked and currently ongoing under IVDr.

      Silvana Furfaro is also Person Responsible for Regulatory Compliance for the reagents manufactured under AD4SEQ brand.

      The company is certified ISO9001 and ISO13485:2016 with the ON BSI Netherlands.

      In 2021, Arrow Diagnostics obtained the EU 2017/746 Regulation assessment, and submitted many Technical Files for the IVDr certification, that became official law last year, at May 26th 2022.

      Being member of the Technical Committee of PharmacomItalia, she has a large experience in Molecular Biology and in pharmaceutical companies (more than 33 years).

      In the past, Mrs. Furfaro worked in pharmaceutical companies as Manager of Quality Control, Quality Assurance, and Manufacturing Departments, improving her knowledge in GMP and GDP.

      Mrs. Furfaro’ s main goal is to contribute at positioning Arrow Diagnostics as one the most important Italian manufacturers in the IVD field, in the next five years

      Session Details:

      Case study: Dealing with a sudden, unexpected and remarkable increase in demand for frozen In-Vitro Diagnostics (IVD) during the Covid-19 pandemic

      2023-03-16, 10:00 AM

      Session Details:

      Panel discussion: Best practice transportation and logistics – cost efficient and reliable transportation solutions

      2023-03-16, 11:30 AM

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      Clément Grenier
      Clinical Supply Project Operational Leader, Sanofi

      After 10 years working in the pharmaceutical transport, 6 years as a Clinical Trial Project Manager for World Courier and 4 years as a Global Cold Chain Manager for Cryopdp, Clément integrated the biopharmaceutical industry in 2019 as a Logistics Specialist for Cellectis, a pioneer biotech in the allogeneic CAR-T Cell therapies. In 2022, Clément joined Sanofi Clinical Supply Chain to implement the Cell therapy clinical programs as a Project Leader.

      Session Details:

      Supply chain and cold-chain-as-a-service (CCaaS): Is outsourcing the next step for biopharmaceutical logistics?

      2023-03-15, 12:15 PM

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      Marco Del Giudice
      CEIV Auditor, Co Founder and VP, PharmacomItalia

      Marco Del Giudice is the founder of the MdG Group comprehending MdG Srl., MdG Consulting and MdG Academy. MdG provides worldwide the pharma and logistic industry with products and services for the cold chain. He has been working in the logistic industry since 1995 and made his first 11 years of experience in companies like Lufthansa Cargo, Trenitalia Cargo and DHL Global Forwarding a Life Science & Healthcare Industry Country Manager. Since 2014 Marco is active for the IATA CEIV Pharma certification as independent validator with more the 95 audits world wide. In 2018 he founded and is still VP of PharmacomItalia, an Italian non-profit association which has members of the pharmaceutical and logistics industry and which deals with common issues of the transport of medicines.

      Session Details:

      Panel discussion: Best practice strategies for regulatory compliance

      2023-03-15, 4:40 PM

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      Paolo Acquafondata
      Vice President and Co-founder, PharmacomItalia and Global Lead Auditing & Compliance, UCB Pharma
      I bring with me a work background of more than 25 years in which I have had the opportunity to hold
      various roles as production manager, supply chain, logistics, quality control, quality assurance in various
      pharmaceutical and in vitro medical device companies in Italy, Europe and worldwide.
      Thanks to this experience, to my knowledge of lean management and to my knowledge of occupational
      health and safety laws, I have been able to build a consultancy business in the creation of quality
      systems in the pharmaceutical, medical device and in vitro diagnostic medical device sectors that take
      into account regulatory requirement by integrating them with company flows, with the Lean philosophy
      and with company profit aspects.
      Since 2018 trainer for notified body BSI on new European regulations for medical devices and IVD
      medical devices.
      Since 2021 Global lead auditor for UCB Pharma.
      I am also project leader of the working group at UNI (Italian Standardisation Body) for the drafting of a
      reference practice on the distribution of pharmaceutical and medical products.

      Session Details:

      Panel discussion: Best practice strategies for regulatory compliance

      2023-03-15, 4:40 PM

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      Stefan Lutzmayer
      PhD, Consultant, IQVIA EMEA Thought Leadership

      Stefan Lutzmayer has over 8 years of experience working in academia and life sciences. He joined the thought leadership team in June 2021 where he is creating novel materials on emerging technology platforms, new developments across therapeutic areas or healthcare policy changes and recently on the pharmaceutical cold chain.

      In his role, he is considered a subject matter expert in these areas, frequently engages with senior client stakeholders, talks at conferences and is involved in consulting projects.

      Stefan has prior experience working as an IT consultant advising healthcare and life sciences clients. He is trained in molecular biology and data analysis and has published multiple peer-reviewed articles in internationally-renown journals.

      Stefan holds a PhD degree in Life Sciences from the University of Vienna.

      Session Details:

      Pharma’s frozen assets: Cold chain medicines

      2023-03-15, 2:30 PM

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      Assil Mohebbi
      Proposal Manager, T°Safe

      Session Details:

      Cloud based temperature tracking & monitoring

      2023-03-15, 9:30 AM

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      Jeroen van Loo
      Global Business Manager, ELPRO

      Jeroen van Loo is a Global Business Manager at ELPRO Global.  Jeroen helps customers take care of efficiency and compliance throughout the supply chain. He can identify global cold chain needs and translate these into solutions.

      16 years of experience within cold chain for the pharmaceutical industry, makes him an expert in the field. Ambition is to provide added value in this field to international organizations.

      Jeroen is available at jeroen.vanloo@elpro.com or https://www.linkedin.com/in/jeroenvanloo/

      Session Details:

      Temperature control: Biopharma supply chain challenges data management can solve

      2023-03-15, 11:45 AM

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