Clinical Trials Supply Chain Congress 2016 Europe

SL51

The clinical trial supplies market is expected to reach USD 1,274.3 million by 2020 from USD 904.3 million in 2015, at a CAGR of 7.1%. (Reportlinker’s Clinical Trial Supplies Market by Products & Services, Phases & Therapeutic Areas – Global Forecast to 2020 2015).

The driving forces behind this phenomenon is the globalization of clinical trial activities, upwards in R&D investments and government support, rising incidences of various diseases and growing expansion activities by CROs.

With these in mind, Clinical Trials Supply Chain Global Congress 2016 Europe is being organised to provide a unique platform for business knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, as well as regional and local manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the clinical trials supply chain industry.

Who Will You Meet

Presidents, Heads/Chiefs, Directors, VPs and Managers of:

• Clinical Supply Chain
• Clinical Supply Specialist
• Clinical Operations
• Clinical Coordination
• Clinical Supply Planning
• Clinical Materials
• Clinical Logistics / Distribution
• Clinical Purchasing
• Clinical Packaging / Labelling
• Clinical Manufacturing
• Clinical Technical Specialist
• Comparator Specialist/ Sourcer
• Vendor Management/ Contracting
• Lean Processes
• Sourcing

Gain Latest Insights On

• PROCESS EXCELLENCE: How Much Influence Does Clinical Trial Supply Has On the Entire Planning Process?
• FLEXIBLE SCHEDULING: Coordinating a Project Efficiently
• NEW EU CLINICAL TRIAL REGULATION: What You Need to Know?
• STORAGE AND DISTRIBUTION: Maintaining Quality and Product Integrity
• PATIENT-CENTRIC APPROACH: Improving Clinical Trial Supply Chain

david-jefferys Dr David Jefferys, Senior Vice President – Global Regulatory, Public Affairs, EISAI, UK
David is currently Senior Vice president in Eisai, responsible for Global Regulatory, Government Relations, Public Affairs and Product Safety. After qualifying in medicine, he practised as a physician and cardiologist, with additional interests in metabolic medicine and
clinical toxicology. He spent 21 years as a senior regulatory in the UK and Europe. He was executive director of licensing in MCA, CPMP member, chairman of the MRFG and PER committees. He was CEO and Director of the UK Medical Devices Agency and on the creation
of the MHRA acting joint chief executive. He worked on secondment at the EMEA /EMA on benefi t risk methodologies.

Since 2005 he has worked for Eisai, currently he is also chairman of the ABPI regulatory committee and a member of the Innovation Board. Within Efpia he chairs the Regulatory Committee and sits on the International Regulatory Board.

He also co -chairs the IFPMA regulatory policy, standards and technical committee (RPTS). He is a past chairman of both RAPS and TOPRA and currently serves as the external relations adviser to the TOPRA Board.

He is a past chairman of the CMR Advisory Board and currently sits as a member of the CIRS Scientifi c advisory Council.


virginie-roux Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE
2001: Human Resource Trainer – French Chamber of Commerce and Industry in Morocco
2004-2007: IMP Logistic Manager at Clinical Supply Chain – Sanofi R&D Montpellier
2007-2010: Supply Chain Trial Manager, Leader in the Internal Medicine Projects at Clinical Supply Chain – Sanofi R&D Montpellier
2010-2013: Distribution Project Manager at Clinical Supplies Scientifi c Core Platform – Sanofi R&D Montpellier
2013-today: TSOM Leader: manager of a projects managers’ team in charge of the packaging and the distribution of supplies (IMP)
for R&D and GMA studies at Clinical Supplies Scientifi c Core Platform – Sanofi R&D Montpellier


leyla Leyla Hannbeck, Chief Pharmacist, National Pharmacy Association
Leyla is a pharmacist by profession and an expert in UK and EU medicines and pharmacy policy and practice, patient safety and medicines adherence, medicines management and commissioning and NHS policies. She currently holds the role of Chief Pharmacists
at the National Pharmacy Association (NPA) leading a team of healthcare professionals and has the overall accountability for the NPA policy and practice support functions, learning and development for healthcare professionals and business development functions.
Leyla represents the organisation and its members to stakeholders and the media and regularly works with commissioners and decision-makers in infl uencing policies related to medicines and healthcare. Leyla is also Medicines Safety Offi cer on behalf of all
pharmacy organisations with less than 50 branches working very closely with NHS England and Medicines Health regulatory Agency
(MHRA).


carlos-r-cammozzi Dr. Carlos R. Camozzi, Chief Medical Offi cer, ORPHAZYME, DENMARK
Dr. Carlos Camozzi is the Chief Medical Offi cer of Orphazyme (Denmark). He has more than 25 years’ experience in the biopharmaceutical industry, most recently (10 years) within the orphan drugs development and paediatric therapeutic options, and successful achievements
of products approvals by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Prior to Orphazyme, Dr. Camozzi held roles of increasing responsibility at American Cyanamid (Lederle), Roche and Mepha Ltd. He was the Medical Director of Orphan Europe-Recordati and VP-Chief Medical Offi cer of uniQure BV (ex-AMT) for the development of genetherapy (GT) for rare diseases, getting the fi rst ever GT approval (Glybera) in western world.


alexander-natz Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM
Since 2009, Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in
Brussels and works as lawyer in his own law fi rm in Düsseldorf (www.natz-law.com). From 2008 to 2013, he was Head of the Brussels
Offi ce of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany
with a special focus on discount agreements and licensing of pharmaceuticals. Dr. Natz also was working in the fi eld of competition
law with the European Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with
international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich
Everling.


michel-mikhail Dr. Michel Mikhail, Pharmaceutical industry Expert, Germany
Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generic industry.
Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail is an Expert in Biosimilars. He served on the Safety working group and Effi cacy working Group of the European Federation
of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Board, Executive Committee and the Biosimilars & Regulatory and Scientifi c Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organisations. He is member of The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is and member of the Expert Committee of the Federal Institute for Risk Assessment, Berlin, and member of the Expert Committee for Toxicology of the United States Pharmacopea (USP), Washington DC.


michael-richter Dr. Michael Richter,
Education: Biochemist (University Halle and University Ulm, Germany)
Job Experiences
Science, Marketing, Microbiology
Since 1999 in Investigational Medical Product department F. Hoffmann La- Roche Basel
Clinical Demand and Supply Leader 2005 – 2015
Head Simulation Clinical Supply Chain 2009-2015
Since May 2015: Quality Manager for IMP Europe, deputy Responsible Person IMP


Piete-Kassen Pieter Kassen


laween-alatroshie Laween Al-Atroshi, Chief Research Officer, Mid-Essex Hospital NHS Trust.
Laween Al-Atroshi, was seconded to Central Government (UK Department of Health) for a year to the Clinical Governance Team. He is currently the Chief Research Offi cer for Mid-Essex NHS Trust. The Trust provides a county-wide plastics, head and neck and upper
gastrointestinal (GI) surgical centre to a population of 3.4 million and a world renowned supra regional burns service at the St Andrew’s Centre, that serves a population of 9.8 million. He is the Good Clinical Practice program lead for North Thames network and also was Labour Party’s Parliamentary candidate for Surrey Heath. In his spare time, he is involved in philanthropic activities where he guests on programmes across the media. Recently, he was a
speaker at the Exclusive Digital Marketing Innovation Summit in London on ‘Marketing Hurdles Digital Media Must Overcome’.


samanthat-carnicj Dr Samantha Carmichael, Lead Pharmacist Clinical Trials / R&D, Clinical R & D, NHS GREATER GLASGOW AND CLYDE
Samantha Carmichael has over 20 years experience as a pharmacist, having spent time in many different areas of pharmacy, including hospital pharmacy and within the private sector working for a large international pharmaceutical company. She is currently the Lead
Pharmacist for Clinical Trials and Research & Development within NHS Greater Glasgow & Clyde where she is also one of the Lead Sponsor Representatives when they act as a non-commercial sponsor of studies . NHS Greater Glasgow & Clyde is the largest
healthboard in the UK, providing healthcare services to a population of 1.2 million in the West of Scotland. She manages a team of pharmacists and pharmacy technicians who deliver on studies sponsored by NHS GGC or co-sponsored with the University of Glasgow,
as well as hosting around 400 CTIMPs across all phases and therapeutic areas. She has practised as a clinical pharmacist in the areas of oncology, critical care and anaesthetics. As well as her Pharmacy degree from the University of Strathclyde, she received an MSc
in Clinical Pharmacology from the University of Glasgow and a PhD in Population Pharmacokinetics, from the University of Edinburgh.


Senior Representative from Sanofi , India – Awaiting Photo and Bio


Senior Representative from Takeda UK – Awaiting Photo and Bio

08:00 Registration


09:00 Chairperson’s Opening Remarks

MAXIMISING CLINICAL SUPPLIES IN THE PLANNING PROCESS


09:10 Achieving Process Excellence in the End-to-End Clinical Trial Supply Chain

• Recognising clinical trial supply chain as a key component to the planning process
• What fundamental improvements should be incorporated in the clinical trial supply chain in progressing the growth of pharmaceutical and
biotechnology companies?
Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM


09:50 What Are Some of the Strategies and Approaches in Optimising the Clinical Trials Supply Chain?

• Review regulatory considerations pertaining to patient safety and aligning your organisation’s clinical strategies effectively
• What are some of the ways organisations can stay compliant and up to speed with global and regional regulations?
• Identify issues which are delaying your supply chain
• How can you build best practice risk management approach into your clinical trial supply chain?
Panellists:
Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM
Dr. Laween Al-Atroshi, Chief Research Offi cer, MID-ESSEX HOSPITAL NHS TRUST
Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde


10:30 Morning Break & Networking


11:10 Costs Explained: How Can Companies Cut Costs in Clinical Trials Supply Chain Whilst Maintaining Safety and Effi cacy of Their Products?

• What are some of the ways at which companies can reduce costs whilst mitigate risks?
• What are some of the solutions available and how effective are these solutions?
• How can outsourcing of clinical trials supply and logistics services reduce costs ensure that materials reach trial sites in a timely,
effi cient manner?
Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM*


11:50 End-to-End Approach in Clinical Supply Chain – The Challenge of Blinding

• Kit separation as reason for unblinding accidents in clinical trials and how to avoid it
• packaging strategies to avoid unblinding accidents
• I(x)R support to avoid unblinding accidents
• challenges for blinding at bulk level
• quality by design instead of quality by control in release process
Dr. Michael Richter, Quality Manager – Global Clinical Supply, ROCHE, SWITZERLAND


12:30 Networking Lunch


13:30 Clinical trial Regultion and update on its delayed implementation till 2018 instead of 2016.
• EU Clinical Trial Regulation Update
• Background/Effective date/ transition period
• Key provisions/Benefits
• Single Authorisation
• EU Clinical Trial Portal and Database – Critical Path
Dr. Michel Mikhail, Phamaceutical Industry Expert, Germany


14:10 The EU Clinical Trial Regulation: What You Need to Know

• What are the advantages for pharma companies with the new regulation?
• What do companies have to do to prepare for the new regulation?
Dr. David Jefferys, Senior Vice President – Global Regulatory, Public Affairs, EISAI, UK


14:50 Tea Break & Networking


15:30 How Has the New European Good Distribution Practice (GDP) Increased the Demand for Clinical Trials Supply Chain Industry?
• What roles do pharmaceutical companies play in preparing for inspections concerning the new GDP guidelines and what must be done
to collaborate with their supply chain providers?
• How has the requirement of temperature controlled handling and storage for pharmaceuticals change the industry and what must the industry
do to remain competitive?
• How can companies strategise a good risk-based approach for organising modes of transport and transport processes whilst working with third
party logistics provider?


16.10 Medicines storage, record-keeping, pharmacovigilance, professional indemnity etc?

Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION


16:50 Industry forecast and expectations do not match NHS reality
Pieter J. Klaassen, Director, Previously Operations Manager in the NHS


17:30 Chairperson’s Closing Remark & End of Day 1


17:30 – 18:30 Networking Drinks

08:00 Registration


08:45 Chairperson’s Opening Remarks

INVENTORY MANAGEMENT, DISTRIBUTION & FULFILLMENT


09:10 Lean and Mean: Lean Management as a Tool to Improve the Clinical Trial Supply Clinical Supply Logistics for Investigator-Initiated Studies (giving perspective of an academic sponsor – I would included some aspects of patient considerations that we give as we have insight to sponsor & site needs/challenges.)
• Understanding the system impact of the lean management implementation clinical supply chain
• How will lean operation affect cost whilst ensuring treatment and supply continuity?
Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde


09:50 Direct To Patient: Delivery of clinical trial materials from an investigator site, pharmacy, or depot directly to a patient’s home

• Context & Objectives/Advantages
• Process Overview & Regulatory Considerations
• Detailed Procedure
Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE


10:30 Morning Break & Networking


11:10 What Effi cient Methods Are Available When Labelling and Packaging Products?

• How to label time and temperature sensitive products?
• What technologies are available and how will these technologies continue to drive the clinical trials logistics industry?


11:50 Case Study: Ensuring The Safety and Effi cacy of Vaccine Supply for Use in Clinical Trials

• What must sponsors and supply chain managers do to ensure the safe passage of vaccines?
Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientifi c/Clinical Affairs, PFIZER*


12:30 Networking Lunch

PATIENT CENTRICITY


13:30 The Patient-Centric Approach: Improving the Clinical Trial Supply Chain

• What does it truly mean to be patient-centric?
• How can supplies infl uence the patient experience?
• What approaches can stakeholders take to ensure patients’ needs are met?
Panellists:
Dr. Carlos Camozzi, Chief Medical Offi cer, ORPHAZYME, DENMARK
Dr. Laween Al-Atroshi, Chief Research Offi cer, MID-ESSEX HOSPITAL NHS TRUST
Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde


14:10 Direct-to-Patient Distribution Model: Driving Effi ciencies and Improving the Patients’ Experience

• How can sponsors ensure that clinical trial materials are delivered to patients’ home on time and within product specifi cations?
• How to determine that trial materials and specimens are packaged and classifi ed properly according to the country’s regulatory requirements?
Dr. Carlos Camozzi, Chief Medical Offi cer, ORPHAZYME, DENMARK


14:50 Tea Break & Networking


15:30 Opportunities and Challenges for Clinical Research in Emerging Markets

• The challenges in keeping up-to-date on the latest clinical trial regulations and what are the strategies to overcome these challenges?
• How can companies cope with the rapid patient enrollment such as China and India?
• How can companies ensure that healthcare professionals are trained to conduct trials in emerging markets?
Senior Representative from SANOFI, India


16:10 What Technologies Are Available Today to Ensure the Safety and Data Accuracy of Clinical Trials?

• How will technology for clinical trials logistics evolve to cater to multi-location trials?
• How can new technology contribute to the safety and data accuracy of clinical trials?
• How will this change affect emerging markets?
Senior Representative from TAKEDA, UK


16:50 Chairperson’s Closing Remark & End of Conference

spon-multifarma Multipharma

As a partner for your individually-tailored comparator sourcing solutions, our multinational team offers
you all-round service from the planning stage through to material reconciliation. This service includes
market research, procurement, storage, logistics / distribution as well as project management support
for your trials. Our worldwide presence and network enables us to fulfill these services throughout the
duration of your trial. Additional areas of focus of Multipharma include pre-marketing and the sale of
non-licensed pharmaceuticals, including controlled substances, on an individual import basis.

http://www.multipharma.com/


spon-prysm PRISYM ID
World Class Label Management Software
PRISYM ID designs and delivers label management software for organizations that need complete
product auto-identification and lifecycle traceability. With the continual tightening of labeling
regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring
compliance, removing risk and significantly reduce costs by eliminating recalls through labeling
errors. PRISYM ID is the market leader in providing validatable world-class label lifecycle
management, and is trusted for delivering personalized service excellence to clients.

http://www.prisymid.com/

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