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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WHAT TO EXPECT FOR 2023?

150+

Attendees

20+

Exhibitors

25+

Speakers

150+

Attendees

20+

Exhibitors

25+

Speakers

See What It's All About

Agenda

  • 15 Mar 2023
  • 16 Mar 2023
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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

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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

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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

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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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