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
  • Complimentary
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Why attend?

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

8:20 AM

Chairperson’s opening remarks

Speakers

8:30 AM

Opening keynote: End-to-end cold chain integrity – challenges, regulatory expectations & mitigation for business sustainability

  • Quality management strategies for end-to-end cold chain integrity
  • Commitment for compliance of cold chain regulations
  • Collaboration with partners / third parties for effective working relationship
  • Handling of non-conformity / temperature excursion
  • Cold chain risk mitigation / minimization for business sustainability

Speakers

9 AM

Event sponsor presentation

9:30 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 AM

Reserved for T°Safe

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

Reducing the risk of temperature deviations and excursions in the cold chain

  • Identifying risks in the cold chain
  • Minimising and avoiding temperature excursions
  • Utilising temperature monitoring and risk management technologies
  • Risk management strategies for temperature controlled logistics

Speakers

12:45 PM

Event sponsor presentation

1:15 PM

Lunch and networking

2:30 PM

How Artificial Intelligence (AI) will transform the pharmaceutical cold chain and temperature controlled logistics

  • Utilizing machine learning to generate predictive data
  • Using data to deal with environmental hazards in the biopharmaceutical cold chain cycle
  • Understanding the potential of blockchain technologies and how they work

Speakers

3 PM

Event sponsor presentation

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
  • How can we face new dramatic scenarios? Lessons learnt

Speakers

4:10 PM

Afternoon refreshments and networking

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

5:20 PM

Chairperson’s closing remarks

Speakers

5:40 PM

Drinks reception sponsored by IQVIA

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

9 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

9:30 AM

Event sponsor presentation

10 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

10:30 AM

Event sponsor presentation

11 AM

Morning refreshments and networking

11:30 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

12 PM

Event sponsor presentation

12:30 PM

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

  • Outsourcing distribution needs to a single global provider
  • Optimising supply chain efficiency and minimising risk
  • Attaining assurance that your products will be warehoused and handled to the highest standards of quality and regulatory compliance
  • Fully automated services allowing you to monitor your inventory continuously

Speakers

1 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

1:30 PM

Lunch and networking

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: Dealing with challenges at customs and border control when transporting temperature sensitive products

Roundtable 2: Working with frozen and deep-frozen products

Roundtable 3: User insights - logistical challenges with air, road and sea transportation 

4 PM

Chairperson’s closing remarks

Speakers

END OF CONFERENCE

Speakers

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Dr. Wasif Azeem
Senior Director JP Global Quality, Jamjoom Pharma

Dr. Wasif Azeem is Global Quality Head & "Sr. Director" in Jamjoom Pharma a leading pharmaceutical company in MENA / GCC Region

  • Vast progressive experience spanning for more than 30 years with Pharma Industry / academia.
  • Dr. Wasif Azeem holds Ph.D. degree in Drug Chemistry
  • Dr. Wasif had a long career with Abbott laboratories (US based company) in different senior management roles.
  • Dr. Wasif has delivered lectures in large # of international conferences / workshops & also served as conference chairman, Keynote Speaker / moderator several times.
  • Has a Diverse portfolio with in-depth knowledge of Quality Operations of different pharmaceutical dosage forms & acquainted with the global cGMP standards such as PIC/S/ ICH, USFDA, WHO, MHRA, GCC, SFDA etc.
  • Dr. Wasif is a certified "Lead Auditor" and has conducted more than 100 audits of Pharmaceutical plants all around the world.
  • Dr. Wasif has been "Examiner for PhD" and provided services as “Advisor/ subject matter expert” on pharmaceutical aspects by different international Organization.
  • Dr. Wasif is married with three children & loves to read in his free time.

Session Details:

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

2023-03-16, 10:00 AM

Session Details:

Opening keynote: End-to-end cold chain integrity – challenges, regulatory expectations & mitigation for business sustainability

2023-03-15, 8:30 AM

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Dr Kamal Amin
Head Of Clinical Supplies Management, Galderma

Session Details:

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

2023-03-16, 11:30 AM

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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, 10:00 AM

Session Details:

Reducing the risk of temperature deviations and excursions in the cold chain

2023-03-15, 12:15 PM

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Ana Martinez Lozano
Associate Director Distribution & Logistics Quality EMEA Lead, MSD

Session Details:

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

2023-03-16, 10:00 AM

Session Details:

GMP and GDP regulations – understanding your requirements

2023-03-15, 9:30 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, 5:20 PM

Session Details:

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

2023-03-16, 11:30 AM

Session Details:

Chairperson’s opening remarks

2023-03-15, 8:20 AM

Session Details:

Chairperson’s opening remarks

2023-03-16, 8:50 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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Stefania Alvino
Omnichannel Marketing Manager & Digital Orchestrator (HAT) - Specialty Division, 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:

How Artificial Intelligence (AI) will transform the pharmaceutical cold chain and temperature controlled logistics

2023-03-15, 2:30 PM

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Francesca Burberi
Associate Director Six Sigma Projects, Eli Lilly

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, 9:00 AM

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Guillaume Lefert
Senior Manager Vaccines Distribution and Cold Chain
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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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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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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, Quality Assurance Manager, BioMARIC NV

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

2023-03-16, 1:00 PM

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Assil Mohebbi
Proposal Manager, T°Safe

Session Details:

Reserved for T°Safe

2023-03-15, 10:00 AM

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Jeroen van Loo
Global Business Manager, ELPRO Global

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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Plan Your Visit

NH Milano Congress Centre

NH Milano Congress Centre Strada 2a, Milanofiori, Italy, 20057

Event code: CTSEU23/TCLEU23

Dates: 15th-16th March 2023

Venue: NH Milano Congress Centre

Booking link: https://www.nh-hotels.com/event/clinical-trial-supply-europe-and-temperature-controlled-logistics-in-biopharmaceuticals-europe

Room rate (single): €129 (incl. VAT and breakfast)

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SPONSORSHIP ENQUIRIES

Jaz Sidhu

Senior Sponsorship Manager

+44 (0) 207 9472755

SPEAKER ENQUIRIES

Alfred Mani

Senior Conference Producer

+44 (0)20 4540 7582

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Jaz Sidhu

Senior Sponsorship Manager


+44 (0) 207 9472755

SPEAKER ENQUIRIES

To enquire about speaking opportunities for the conference, please contact:

Alfred Mani

Senior Conference Producer


+44 (0)20 4540 7582