Temperature Controlled Logistics in Biopharmaceuticals Europe 2024

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

3 - 4

December

2024

Barcelona, Spain
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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.

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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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Ana Martinez Lozano

Associate Director Distribution & Logistics Quality EMEA Lead, MSD

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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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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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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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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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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 Website

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

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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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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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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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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?

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

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2023 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

Chris Wallace

Former Senior Vice President Supply Chain, Clover Biopharmaceuticals

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

Dr. Wasif Azeem

Senior Director JP Global Quality, Jamjoom Pharma

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

Ana Martinez Lozano

Associate Director Distribution & Logistics Quality EMEA Lead, MSD

10 AM

Reserved for T°Safe

Speakers

Assil Mohebbi

Proposal Manager, T°Safe

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

Sonia Ben Hamida

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

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

Jeroen van Loo

Global Business Manager, ELPRO

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

Gianpiero Lorusso

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

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

Stefania Alvino

Head of Digital Innovation, Daiichi Sankyo

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

Gerardo De Pasquale

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

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

Marco Del Giudice

CEIV Auditor, Co Founder and VP, PharmacomItalia

Paolo Acquafondata

Vice President and Co-founder, PharmacomItalia and Global Lead Auditing & Compliance, UCB Pharma

Francesca Burberi

Associate Director Six Sigma Projects, Eli Lilly

5:20 PM

Chairperson’s closing remarks

Speakers

Chris Wallace

Former Senior Vice President Supply Chain, Clover Biopharmaceuticals

5:40 PM

Drinks reception sponsored by IQVIA