Webinar: A regulators insight to the updated European Commission Guidelines on GDP (2013/C 343/01)

Sponsored by: DHL

Focused on:

  • Maintaining
  • Product
  • Temperature
  • Integrity

Date: 21 May

1101

Time: 3PM London/10AM New York

Focusing on logistics compliance to separate supply chain fact from fiction

A rare opportunity for a quality compliance minded community, to share views on the challenges and organisational preparedness of meeting the transportation requirements of the directive. The new GDP Directive has generated much discussion but little assertion as to how well the industry is prepared to meet the implicit supply change challenge of maintaining product temperature integrity.

This Webinar will allow you to understand:

• What is the regulators view of meeting the required standard
• How well prepared are you versus your industry peers?
• What is the scale and priority of the GDP directive (as a supply chain issue)
• Clarity and alignment on what the requirements for your business are
• What are the potential hazards and pitfalls in achieving compliance
• Who in the industry is setting the pace
• What approaches are being taken to managerisk and attain compliance
• Your personal opportunity to put your questions and queries to the MHRA

Be amongst the supply chain pioneers, sharing candid views on navigating the practical challenges inherent in managing the risk in meeting the requirements of GDP.

Presented by

Tony Orme,

Senior GDP Inspector, Inspection, Enforcement and Standards Division,MHRA

A founder member of the GDP Inspectorate when it was created in 2001, he is a Senior GDP Inspector responsible for inspecting the full range of UK distribution companies.

He is a member of the PIC/S GDP working group, working on the training and aligning of GDP standards for PIC/S member countries. He was part of the EMA GDP drafting group preparing the GDP Guidelines and updates to the compilation of community procedures and involved in training the GMDP inspectors on the new guidelines. He was also a member of the team who reviewed the UK supply chain and looked at ways to improve the standard of the Wholesale Dealer 'Responsible Person'. He is currently a member of the implementation team for the Falsified Medicines Directive and working on developing the new Risk Based Inspection IT system for the MHRA.

Tony has been with the MHRA for 24 years, working initially with the MHRA Enforcement Group where he was a Senior Investigation Officer. As such he was responsible for investigating counterfeit medicines, internet sales and other illegal activity with pharmaceuticals.

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Key Learning Objectives

  • Exploring the revised the guidelines to appreciate the nuances for a 21st Century supply chain challenge.
  • A frank appreciation of where the pharmaceutical industry is 9 months from implementation of the European Commission Guideline.
  • An assessment of the complexity and associated risk formanaging transport temperature control challenges.
  • An inspectors perspective, your chance to qualify your approach.

Audience

  • CEO/President/Chairman/Executive Director
  • Logistics Managers
  • Heads of Quality
  • Regulatory Compliance and Risk Directors
  • Quality Assurance Managers
  • CROs and Biotechnology Firms
  • Operations Directors
  • General Managers
  • Transport Managers