2014 ISPE Investigational Products Conference

Education Programme

Programme Agenda » ( 168 KB)

Investigational Products in a Global Environment

Using case studies and real examples, the focus will be on sharing experiences from the wide range of companies involved in the manufacture and packaging of investigational medicinal products. Networking events designed to continue the discussions initiated in the sessions and offer an opportunity for delegates to make important professional connections in an informal setting will take place throughout the conference. The education programme will include interactive workshops, seminar presentations and case studies, providing a valuable forum to challenge existing preconceptions, explore alternative approaches and to share best practices.

Featured Sessions

Plenary

  • GDP Regulations: Experience and Challenges on One Year in Practice
  • Lessons from Regulated Non-Pharma Industries

Regulatory Panel featuring MHRA and Spanish Inspectorate

  • Belén Escribano Romero, Chief Manager of the Drugs Control and Inspection, AEMPS - Agencia Española De Medicamentos Y Productos Sanitarios, Spain
  • Jason Wakelin-Smith, GCP & GLP Inspector, MHRA, UK

Two Walking Forums with the Regulators

Workshop 1

  • Ensuring Supply Availability
  • New GDP Impact on CT Distribution
  • Outsourcing Challenges: End-to-End vs. Fractionate

Workshop 2

  • Direct Subject Distribution
  • Innovative Patient Solutions
  • GMP/GCP Interface Management

Featured Topics

Clinical Supply Chain, Wednesday 17 September

  • Clinical Supply Chain Metrics Case Study
  • Ensuring Supply Availability
  • New GDP Impact on CT Distribution
  • Outsourcing Challenges: End-to-End vs. Fractionate
  • Lean Supply Chain Application in Clinical Supply
  • Innovative Patient Solutions
  • Blinding End to End

End-to-End On-Site Processes, Thursday 18 September

  • CRO Perspective on Characteristics of Effective GCP/GMP Interface
  • Planning for Effective Close-out Phase
  • Expanded Access Programme
  • Direct Subject Distribution
  • Innovative Patient Solutions
  • GCP/GMP Interface Management
  • Patient Survey Update

Speakers

  • Melanie Blessing, Head Therapeutic Area Supply Chain Management Cardiometabolic Diseases, Boehringer Ingelheim Pharma Gmbh, Germany
  • Sandra Cook, PhD, Owner and President, Cook Consulting LLC, USA
  • Mark Corbett, Independent Pharmceutical Consultant, MEMCOR Ltd, United Kingdom
  • Sebastien Delporte, QA Packaging and Logistics Manager, Eli Lilly and Company, Belgium
  • Massimo Eli, Global Clinical Supply Regional Lead, MSD Italy SrL / Merck Corp., Italy
  • Belén Escribano Romero, Ph.D., Head of the Pharmaceutical Inspection and Enforcement Department, AEMPS - Spanish Agency for Medicinal Products and Medical Devices, Spain
  • David Glynn, Assoc. Director, Project Management, Sunovion Pharmaceuticals Inc, USA
  • Lesley Holt, Global Demand and Supply R&D, GlaxoSmithKline, United Kingdom
  • Christoph Honermann, Global Product Manager Life Science, DACHSER GmbH & Co. KG, Germany
  • Henryk Junker, Deputy Quality Director, Hospira Ltd UK, United Kingdom
  • Meinrad Kopp, Ph.D., Merck,
  • Raffaele Laciti, MBA, Global Category Manager, DSM, Novartis Pharma AG Development Strategic Sourcing, Switzerland
  • Anthony Moult, Director Clinical Supply Operations, Daiichi-Sankyo, United Kingdom
  • Julian Schulz, Associate Director Clinical Supplies, Takeda Global Research & Development Centre, United Kingdom
  • Sascha Sonnenberg, Vice President Commercial Operations, Marken Ltd, Germany
  • Jason Wakelin-Smith, GCP Inspector, MHRA, United Kingdom
  • Terrence Walsh, RPh, MBA, Supply Chain Leader, TransCelerate BioPharma Inc, USA
  • Steven Yoder, MBA, Global Director, Thermofisher Scientific, USA

 Add the event to your calendar

Register Early

Register before 22 August 2014 to save! Discounted rates apply for groups of 3 or more.

HANDOUTS NOW AVAILABLE

FEATURED PLENARY SPEAKERS!

Anthony Moult, EFPIA Representative, Director Clinical Supply Operations, Daiichi-Sankyo, UK

Terry Walsh, Head, Comparator Network, TransCelerate BioPharma Inc., USA

Christoph Honermann, Global Prduct Manager Life Science, DACHSER GmbH & Co. KG, Germany

Belén Escribano Romero, Ph.D. Head of the Pharmaceutical Inspection and Enforcement Department, AEMPS - Spanish Agency for Medicinal Products and Medical Devices, Spain

Jason Wakelin-Smith, GCP & GLP Inspector, MHRA, UK

MEET OUR PROGRAMME COMMITTEE!

Chair: Henryk Junker, Senior Manager, Clinical Quality, Allergan Ltd, UK

Massimo Eli, Ph.D., Clinical Supply Regional Lead, MSD Italia SrL, Italy

Karen Gram, Principal Specialist, Novo Nordisk A/S, Denmark

Marianne Oth, Ph.D., Manager, Quality Assurance, Lilly Clinical Operations SA, Belgium

Esther Sadler-Williams, Global Director, Catalent Pharma Solutions, UK

Julian Schulz, Associate Director Clinical Supplies, Takeda Development Centre, UK

Bernd Steffens, Ph.D., Head Global Clinical Trial Supplies Unit, Boehringer Ingelheim Pharma GmbH & Co., Germany


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