clinical trial supply

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MONDAY – TUESDAY, 11 - 12 APRIL 2016 Hilton London Kensington Hotel, London UK • Dr. Carlos Camozzi, Chief Medical Officer, ORPHAZYME, DENMARK • Dr. David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK • Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM • Dr. Michael Richter, Quality Manager - Global Clinical Supply, ROCHE, SWITZERLAND • Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE • Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION • Dr. Michel Mikhail, Pharmaceutical Industry Expert, Germany • Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientific/Clinical Affairs, PFIZER* • Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM* • Dr. Laween Al-Atroshi, Chief Research Officer, MID-ESSEX HOSPITAL NHS TRUST • Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde Senior Representative from SANOFI, India • Pieter J. Klaassen, Director, Previously Operations Manager in the NHS Senior Representative from TAKEDA, UK FEATURING KEY STAKEHOLDER EXPERTS Clinical Trials Supply Chain Global Congress 2016 Europe Navigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

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Page 1: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UKMONDAY – TUESDAY,

11 - 12 APRIL 2016Hilton London Kensington Hotel, London UK

• Dr. Carlos Camozzi, Chief Medical Offi cer, ORPHAZYME, DENMARK

• Dr. David Jefferys, Senior Vice President - Global Regulatory, Public Affairs, EISAI, UK

• Dr. Alexander Natz, Secretary General, EUROPEAN CONFEDERATION OF PHARMACEUTICAL ENTREPRENEURS (EUCOPE), BELGIUM

• Dr. Michael Richter, Quality Manager - Global Clinical Supply, ROCHE, SWITZERLAND

• Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE

• Leyla Hannbeck, Chief Pharmacist, NATIONAL PHARMACY ASSOCIATION

• Dr. Michel Mikhail, Pharmaceutical Industry Expert, Germany

• Dr. Amgad Gamil, Senior Director, Vaccines Global Medical Development and Scientifi c/Clinical Affairs, PFIZER*

• Dr. Bernd Steffens, Director and Global Head Clinical Trial Supplies Unit, BOEHRINGER INGELHEIM*

• Dr. Laween Al-Atroshi, Chief Research Offi cer, MID-ESSEX HOSPITAL NHS TRUST

• Samantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde

• Senior Representative from SANOFI, India

• Pieter J. Klaassen, Director, Previously Operations Manager in the NHS

• Senior Representative from TAKEDA, UK

FEATURING KEY STAKEHOLDER EXPERTS

Clinical Trials Supply Chain GlobalCongress 2016 Europe

Navigating the Challenging Waters of the ClinicalTrials Supply Chain Landscape

Page 2: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

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 busi-ness 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

Gain Latest Insights On

Pres iden ts , Heads/Ch ie fs , D i rec to rs , VPs and Managers o f :

• Clinical Supply Chain

• Clinical Supply Specialist

• Clinical Operations

• Clinical Coordination

• Clinical Supply Planning

• Clinical Materials

• Clinical Logistics / Distribution

• Clinical Purchasing

• 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

• Clinical Packaging / Labelling

• Clinical Manufacturing

• Clinical Technical Specialist

• Comparator Specialist/ Sourcer

• Vendor Management/ Contracting

• Lean Processes

• Sourcing

Monoclonal Antibody Congress 2014 EuropeLatest Innovations on Discovery, Production and Application

27-28 October 2014 | Hilton Kensington | London, UK

Dear Colleagues,

Monoclonal Antibodies are also known as targeted therapiesbecause they work by targeting specific proteins on the surface ofthe cells. Mabs agents are currently have been successfully used in the treatment of cancers, tumors and other serious diseases and is big on the market.

The market size of Monoclonal antibody agents in 2009-2012 grew at a CAGR of 13% and is expected to rise by more than 12% in2013-2017 reaching $141 billion in 2017. This is due to greatmarket demand, new products being approved and also launchingof Mabs generic drugs.

The global industry of Mabs is currently dominated by Europeanand American companies, however, sales of Mabs in the rest of theworld will remain higher than in the U.S despite a higher CAGR inthe U.S.

By Attending this conference you will:

Gain insight on various therapeutic targets Learn the latest and most recent advances in antibody

technology Find out what is the future in antibody technology Understanding about new antibody engineering and

modification technologies Explore up to date platform approaches to monoclonal

antibody purification Learn new techniques in cell engineering for Mabs

production Examine antibody-based targeted therapy Study the latest trends in capacity utilization for

therapeutic mabs production Investigate immunogenicity issues with drug

development Hear about latest regulations, technologies, production

and therapeutics

Who shall attend?VP’s, Directors, Heads and Managers of:

• Antibody Development• Preclinical research development• Clinical Research development• Cell and Molecular Biology• Recombitant DNA Biotechnology• Auto-immune Disorders• Pharmaceutical and Patent Law• Contract research Organizations• Clinical Diagnostics• New product development• Oncology R&D• Business Development• Marketing

I look forward to meeting you at the conference.

Best Regards,

Jocelyn RaguindinConference DirectorParadigm Global [email protected]

By Attending you will be exposed to:

New Technologies, Innovations and Concept New Product and Trends Addressing the common issues and Solutions to

overcome Networking with Service Providers Establish, network and source opportunities with major

suppliers Gain new ideas that offers real value to your business Listen to key industry expert speakers who are in the

know and discuss major issues with a broad range ofother senior level business executive leaders andestablish rapport.

Register now for a group Discount.

To register contact: Kimberly TecsonTel No: +44 (0) 207 193 3485Email Address: [email protected]

To Book Call: +44 (0) 207 193 3485 / Email: [email protected] / www.paradigmglobalevents.com

Hilton London Kensington179-199 Holland Park Ave, London

W11 4UL, United Kingdom

Reservations: 020 7603 3355

Web: www.hilton.com

Monoclonal Antibody Congress 2014 EuropeLatest Innovations on Discovery, Production and Application

27-28 October 2014 | Hilton Kensington | London, UK

Dear Colleagues,

Monoclonal Antibodies are also known as targeted therapiesbecause they work by targeting specific proteins on the surface ofthe cells. Mabs agents are currently have been successfully used in the treatment of cancers, tumors and other serious diseases and is big on the market.

The market size of Monoclonal antibody agents in 2009-2012 grew at a CAGR of 13% and is expected to rise by more than 12% in2013-2017 reaching $141 billion in 2017. This is due to greatmarket demand, new products being approved and also launchingof Mabs generic drugs.

The global industry of Mabs is currently dominated by Europeanand American companies, however, sales of Mabs in the rest of theworld will remain higher than in the U.S despite a higher CAGR inthe U.S.

By Attending this conference you will:

Gain insight on various therapeutic targets Learn the latest and most recent advances in antibody

technology Find out what is the future in antibody technology Understanding about new antibody engineering and

modification technologies Explore up to date platform approaches to monoclonal

antibody purification Learn new techniques in cell engineering for Mabs

production Examine antibody-based targeted therapy Study the latest trends in capacity utilization for

therapeutic mabs production Investigate immunogenicity issues with drug

development Hear about latest regulations, technologies, production

and therapeutics

Who shall attend?VP’s, Directors, Heads and Managers of:

• Antibody Development• Preclinical research development• Clinical Research development• Cell and Molecular Biology• Recombitant DNA Biotechnology• Auto-immune Disorders• Pharmaceutical and Patent Law• Contract research Organizations• Clinical Diagnostics• New product development• Oncology R&D• Business Development• Marketing

I look forward to meeting you at the conference.

Best Regards,

Jocelyn RaguindinConference DirectorParadigm Global [email protected]

By Attending you will be exposed to:

New Technologies, Innovations and Concept New Product and Trends Addressing the common issues and Solutions to

overcome Networking with Service Providers Establish, network and source opportunities with major

suppliers Gain new ideas that offers real value to your business Listen to key industry expert speakers who are in the

know and discuss major issues with a broad range ofother senior level business executive leaders andestablish rapport.

Register now for a group Discount.

To register contact: Kimberly TecsonTel No: +44 (0) 207 193 3485Email Address: [email protected]

To Book Call: +44 (0) 207 193 3485 / Email: [email protected] / www.paradigmglobalevents.com

Hilton London Kensington179-199 Holland Park Ave, London

W11 4UL, United Kingdom

Reservations: 020 7603 3355

Web: www.hilton.com

Monoclonal Antibody Congress 2014 EuropeLatest Innovations on Discovery, Production and Application

27-28 October 2014 | Hilton Kensington | London, UK

Dear Colleagues,

Monoclonal Antibodies are also known as targeted therapiesbecause they work by targeting specific proteins on the surface ofthe cells. Mabs agents are currently have been successfully used in the treatment of cancers, tumors and other serious diseases and is big on the market.

The market size of Monoclonal antibody agents in 2009-2012 grew at a CAGR of 13% and is expected to rise by more than 12% in2013-2017 reaching $141 billion in 2017. This is due to greatmarket demand, new products being approved and also launchingof Mabs generic drugs.

The global industry of Mabs is currently dominated by Europeanand American companies, however, sales of Mabs in the rest of theworld will remain higher than in the U.S despite a higher CAGR inthe U.S.

By Attending this conference you will:

Gain insight on various therapeutic targets Learn the latest and most recent advances in antibody

technology Find out what is the future in antibody technology Understanding about new antibody engineering and

modification technologies Explore up to date platform approaches to monoclonal

antibody purification Learn new techniques in cell engineering for Mabs

production Examine antibody-based targeted therapy Study the latest trends in capacity utilization for

therapeutic mabs production Investigate immunogenicity issues with drug

development Hear about latest regulations, technologies, production

and therapeutics

Who shall attend?VP’s, Directors, Heads and Managers of:

• Antibody Development• Preclinical research development• Clinical Research development• Cell and Molecular Biology• Recombitant DNA Biotechnology• Auto-immune Disorders• Pharmaceutical and Patent Law• Contract research Organizations• Clinical Diagnostics• New product development• Oncology R&D• Business Development• Marketing

I look forward to meeting you at the conference.

Best Regards,

Jocelyn RaguindinConference DirectorParadigm Global [email protected]

By Attending you will be exposed to:

New Technologies, Innovations and Concept New Product and Trends Addressing the common issues and Solutions to

overcome Networking with Service Providers Establish, network and source opportunities with major

suppliers Gain new ideas that offers real value to your business Listen to key industry expert speakers who are in the

know and discuss major issues with a broad range ofother senior level business executive leaders andestablish rapport.

Register now for a group Discount.

To register contact: Kimberly TecsonTel No: +44 (0) 207 193 3485Email Address: [email protected]

To Book Call: +44 (0) 207 193 3485 / Email: [email protected] / www.paradigmglobalevents.com

Hilton London Kensington179-199 Holland Park Ave, London

W11 4UL, United Kingdom

Reservations: 020 7603 3355

Web: www.hilton.com

hilton london kensington179-199 holland park ave, London w11 4ul, united kingdom

reservations: 020 7603 3355website: www.hilton.com

Page 3: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

Key Industry Expert Speakers

Virginie Roux, TSOM Leader, Clinical Supplies SCP – Studies & Distribution, SANOFI, FRANCE

2001: Human Resource Trainer - French Chamber of Commerce and Industry in Morocco2004-2007: IMP Logistic Manager at Clinical Supply Chain – Sanofi R&D Montpellier2007-2010: Supply Chain Trial Manager, Leader in the Internal Medicine Projects at Clinical Supply Chain – Sanofi R&D Montpellier2010-2013: Distribution Project Manager at Clinical Supplies Scientifi c Core Platform – Sanofi R&D Montpellier2013-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 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).

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 gene-therapy (GT) for rare diseases, getting the fi rst ever GT approval (Glybera) in western world.

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.

Page 4: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

Key Industry Expert Speakers

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.

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.

Dr. Michael Richter,

Education: Biochemist (University Halle and University Ulm, Germany)Job ExperiencesScience, Marketing, Microbiology

Since 1999 in Investigational Medical Product department F. Hoffmann La- Roche BaselClinical Demand and Supply Leader 2005 – 2015Head Simulation Clinical Supply Chain 2009-2015Since May 2015: Quality Manager for IMP Europe, deputy Responsible Person IMP

Pieter Klassen

Page 5: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

Key Industry Expert Speakers

Laween Al-Atroshi, Chief Research Offi cer, 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’.

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

Page 6: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

1st DAY OF CONGRESS | MONDAY, 11 APRIL 2016

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

<Presentation> • 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?

<Panel Discussion> • 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), BELGIUMDr. Laween Al-Atroshi, Chief Research Offi cer, MID-ESSEX HOSPITAL NHS TRUSTSamantha 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 cacyof Their Products?

<Presentation> • 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

<Presentation> • 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

Page 7: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

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

<Presentation> • 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?

<Presentation>• 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?

<Presentation>

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

Page 8: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

2nd DAY OF CONGRESS | TUESDAY, 12 APRIL 2016

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 SupplyClinical Supply Logistics for Investigator-Initiated Studies (giving perspective of an academic sponsor – I would included some aspects of patientconsiderations 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

<Presentation> • 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?

<Presentation> • 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

<Presentation> • 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

INVENTORY MANAGEMENT, DISTRIBUTION & FULFILLMENT

Page 9: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

PATIENT CENTRICITY

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

<Panel Discussion> • 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, DENMARKDr. Laween Al-Atroshi, Chief Research Offi cer, MID-ESSEX HOSPITAL NHS TRUSTSamantha Carmichael, Lead Pharmacist Clinical Trials, NHS Greater Glasgow & Clyde

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

<Presentation> • 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

<Presentation> • 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?

<Presentation> • 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

PATIENT CENTRICITY

Page 10: Clinical Trial Supply

TEl: +44 (0) 207 193 3485Email: [email protected]: www.paradigmglobalevents.com

Clinical Trials Supply Chain Global Congress 2016 EuropeNavigating the Challenging Waters of the Clinical Trials Supply Chain Landscape

MONDAY – TUESDAY, 11 - 12 APRIL 2016HILTON LONDON KENSINGTON HOTEL, LONDON, UK

11

Biosimilars Global Congress 2014 EuropeRegistration form

17th - 19th September 2014 | London, UK

Standard Price Per Delegate: Conference Only £1299 + VAT

Discount Code: _______________

Distribution of promotional literature : £700 +Vat Distribution of your company’s promotional literature to all the attendees

Date of Booking:

Title:

Forename: Surname:

Company:

Job Title:

Department / Division:

Main Switchboard Number:

Address:

Post /Zip Code:

Direct Line: Direct Fax:

Mobile:

Direct Email Address:

Signature: I confirm that I have read and agree to the terms and conditions of the booking.

Please debit my credit card:

MasterCard Visa American Express

Card Number:

Valid From: Expiry Date:

Security number 3digits security on reserve of card. 4 digits for Amex at the front

Signature

Card Holder’s Name

Methods of Payment: Payment must be made in sterling

By Electronic Bank Transfer: Please transfer the full funds to Paradigm Global Events Ltd using the following account details:

Paradigm Global Events LtdA/C: Paradigm Global Events Ltd Royal Bank of Scotland Sort Code: 160058 Account Number: 11010989 Royal Bank of Scotland 40 Islington High Street London, N1 8XB, UK Swift Code: RBOSGB2L IBAN: GB93 RBOS 16005811010989

By Phone: Call us on +44 (0) 207193 3485 with your credit card details Fax No: +44 (0) 208 930 2142

Terms and Conditions of Booking

Formation and Incorporation: There is a 50% liability on all bookings once made, whether by fax, email or by post. Receipt of this booking form, inclusive or exclusive of payment constitutes formal agreement to attend and acceptance of the terms and conditions stated and are sold on a firm sales basis.

Payment Terms Paradigm Global Events Ltd requires full payment of the amount to be made at the time of booking via credit card. We reserve the right to decline any booking for the event. If payment is not made at the time of the booking an event, then an invoice will be issued and must be paid in full within 14 days from the date of the booking stated on the invoice and immediately prior to the event. A credit card guarantee may be requested if the full payment has not been received in full before the event and payment will be taken before entry to the event. We are unable to allow a delegate to attend an event or have access to the Document Portal unless payment has been received in full by us prior to commencement of the event. Paradigm Global Events reserves the right to charge interest on unpaid invoices.

Cancellation The event organized by Paradigm Global Events Ltd, a limited liability company formed under English company law and registered in the UK. Cancellations received in writing more than 45 days before the conference date, will be eligible for 50% of the due less a £75 administration fee. If you are unable to send substitution then Cancellations must be made in writing. Cancellations made less than 45 days before the event date will not be entitled to a refund.

Substitutions / Name Changes If you are unable to attend you may nominate, in writing, another delegate to take your place any time prior to the start of the events. Two or more delegates may not share a place at an event. Please make separate bookings for each delegate.

Alterations Paradigm Global Events Ltd reserves the right to make alterations to the event / executive briefing content, timing, speakers or program and venues beyond our control. The event may be postponed or cancelled due to unforeseen events beyond the control of Paradigm Global Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any transport disruption or individual transport delays and in such circumstances the normal cancellation restrictions apply.

Data Protection The information that we collect and store relating to you is primarily used to enable us to provide our services to you, to respond to your inquiries about our offerings, and to offer you other products, programs or services that we believe may be of interest to you. We sometimes use such information to communicate with you. If you choose to submit content for event publication or event program, we may publish your name and other information you have provided to us. If you are a previous or existing customer, we may contact you with information about products and services similar to those, which were the subject of a previous sale to you. Furthermore, we may use your data, or permit selected third parties to use your data, so that you can be provided with information about unrelated products and services which we consider may be of interest to you. We or they may contact you about these products and services by any methods that you consented at the time your information was collected. As set out above, we are committed to safeguarding your personal information. Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information, including the Data Protection Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection laws”

Fee: The event fee includes lunch, refreshments and conference documents provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance.

Payment of Invoice Our aim is to establish and maintain a long-term business relationship with all our clients and customers, however failure to pay in accordance with clause causes us significant problems and expense in chasing late payers. For late payers we will take action to enforce full payment of the invoice, and without prejudice any other rights, to terminate the contract with you in respect of any future supplies and to compensation for debt recovery cost under “The Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by “The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees (minimum £40) will be payable to offset our costs in this matter. We may set and vary credit limits from time to time and may not accept any further orders if such credit limits are exceeded. If you have a problem with any product or service please contact us immediately and we will try and resolve the issue. You should however pay the invoice in full by the duedate to prevent further action!

Delegate Details

Terms and Conditions of Booking

Formation and Incorporation: There is a 50% liability on all bookings once made, whether by fax, email or by post. Receiptof this booking form, inclusive or exclusive of payment constitutes formal agreement to attend and acceptance of the terms and conditions stated and are sold on a firm sales basis.

Payment Terms Paradigm Global Events Ltd requires full payment of the amount to be made at the time ofbooking via credit card. We reserve the right to decline any booking for the event. If payment is not made at the time of the booking an event, then an invoice will be issued and must be paid in full within 14 days from the date of the booking stated on the invoice and immediately prior to the event. A credit card guarantee may be requested if the full payment has not been received in full before the event and payment will be taken before entry to the event. We areunable to allow a delegate to attend an event or have access to the Document Portal unlesspayment has been received in full by us prior to commencement of the event. ParadigmGlobal Events reserves the right to charge interest on unpaid invoices.

Cancellation The event organized by Paradigm Global Events Ltd, a limited liability company formed under English company law and registered in the UK. Cancellations received in writing more than 45 days before the conference date, will be eligible for 50% of the due less a £75 administration fee. If you are unable to send substitution then Cancellations must be made in writing.Cancellations made less than 45 days before the event date will not be entitled to a refund.

Substitutions / Name Changes If you are unable to attend you may nominate, in writing, another delegate to take your place any time prior to the start of the events. Two or more delegates may not share a place at an event. Please make separate bookings for each delegate.

Alterations Paradigm Global Events Ltd reserves the right to make alterations to the event / executive briefing content, timing, speakers or program and venues beyond our control. The event maybe postponed or cancelled due to unforeseen events beyond the control of Paradigm Global Events Ltd. We have no liability for any loss of trade or profit occurring to the customer as a result of a charge or cancellation. Paradigm Global Events Ltd will not accept liability for any transport disruption or individual transport delays and in such circumstances the normal cancellation restrictions apply.

Data Protection The information that we collect and store relating to you is primarily used to enable us to provide our services to you, to respond to your inquiries about our offerings, and to offer you other products, programs or services that we believe may be of interest to you. We sometimes use such information to communicate with you. If you choose to submit content for event publication or event program, we may publish your name and other information you have provided to us. If you are a previous or existing customer, we may contact you with information about products and services similar to those, which were the subject of a previous sale to you. Furthermore, we may use your data, or permit selected third parties to use your data, so that you can be provided with information about unrelated products and services which we consider may be of interest to you. We or they may contact you about these products and services by any methods that you consented at the time your information wascollected. As set out above, we are committed to safeguarding your personal information.Whenever you provide such information, we are legally obliged to use your information in line with all laws concerning the protection of personal information, including the Data Protection Act 1998 (these laws are referred to collectively in this Privacy Policy as the “data protection laws”

Fee:The event fee includes lunch, refreshments and conference documents provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance.

Payment of InvoiceOur aim is to establish and maintain a long-term business relationship with all our clients and customers, however failure to pay in accordance with clause causes us significant problems and expense in chasing late payers. For late payers we will take action to enforce fullpayment of the invoice, and without prejudice any other rights, to terminate the contract with you in respect of any future supplies and to compensation for debt recovery cost under “The Late Payment of Commercial Debts (Interest)” Act 1998 as amended and supplemented by “The Late Payment of Commercial Debts Regulations 2002”. In jurisdictions where this may not apply you accept that equivalent interest (8% above UK base rate) and debt recovery fees(minimum £40) will be payable to offset our costs in this matter. We may set and vary credit limits from time to time and may not accept any further orders if such credit limits are exceeded. If you have a problem with any product or service please contact us immediately and we will try and resolve the issue. You should however pay the invoice in full by the duedate to prevent further action!

Delegate Details

Card Billing Address:

Direct Tel: Direct Mobile:

Email address:

Card Holder’s Signature:

By Electronic Bank Transfer: Please transfer the full funds to Paradigm Global Events Ltd bank account.

Methods of Payment: All payment must be made in Sterling.