GDP PART - 24 June 2021

Moderated by: Dr Afshin Hosseiny

It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. Th is is where Good Distribution Practice (GDP) comes into play. On day 3, challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.

GDP Update & Outlook

  • Major GDP developments

Dr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association 

Case Studies: When Things go Wrong – What can Happen in the Real World?

  • First plan, then start
  • Hand in hand for safe transport
  • Basis of all considerations “Worst Case Scenario”

Axel Radke, Trust Expertenservice 

Case Study: The Switch from Air-freight to Sea-Freight

  • Challenges and Benefits 
  • Examples

Saddam Huq, GlaxoSmithKline 

GDP Challenges in Africa

  • Background 
  • Evolution of GDP over the years
  • Problems involved 
  • Steps taken to improve

Maria Sekamwa, Surgipharm 

Performance beyond Compliance

  • Efficient GDP quality policy
  • GDP-relevant quality targets
  • Helpful benchmarks for auditors
  • Critical review of GDP certificates

Dr Torsten Schmidt-Bader, moveproTEC Compliance & Innovation Advisory

Master Data

  • EU requirements
  • Master Data framework for Medicines 
  • Impact to the Pharmaceutical Supply Chain
  • QA/QP/RP oversight of the supply chain

Cheryl Chia, Lotus Phoenix Consulting

GDP Responsibilities for Financial Trading Organisation

  • Involvement of Marketing Authorisation Holders in the distribution network
  • The role of the Responsible Person when product handling is not involved
  • Control of outsourced activities in integrated supply chains 
  • Processes used in financial distribution, and validation of computerised systems

Prabjeet Dulai, GDP & Quality Matters &  Jonathan Riley, Astellas Pharma Europe 

Final Q&A Session (Day 3)