TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Umit Kartoglu
  2. Supply chain and logistics
  3. Sunday, 09 February 2020

Dear Colleagues,

The bus is ready to hit the road again!

I am happy to announce the fothcoming award winning renown bus course "Pharmaceutical Secure Supply Chain Management on Wheels" is now acepting applications.

For full details please refer to the attached Introduction document which has online application link on page 7. For easy reference I copy the link here as well: http://bit.ly/2QrHKky

We are much looking forward to seeing you on board. 

Dr Umit Kartoglu/Course Director

umit@kartoglu.ch 

 

INTRODUCTION

Members of the pharmaceutical supply chain have various global requirements to meet during the storage, transport and handling of time and temperature sensitive products. Changing product portfolios, requirements for good storage and distribution practices, regulatory expectations, quality management, security, and quality risk management bring many challenges to pharmaceutical safe supply chain management.

This learning event is brought to you by its creators, Extensio et Progressio (Switzerland) and Tip Kurumu (Turkey). The purpose in offering this unique learning event is to provide key players of the pharmaceutical supply chain an opportunity to gain insights into complete supply chain operations and oversight from product manufacture (or arrival in a country) to the product’s administration to the patient via experiential learning approach. This is done by bringing together a group of participants from the national regulatory authorities and pharmaceutical, biopharmaceutical, vaccine industry involved in the supply, packaging, distribution, logistics and cold chain management areas as well as industry members of immunization related equipment and device manufacturers.

COURSE OBJECTIVES

Pharmaceutical Secure Supply Chain Management on Wheels (PSSCMoW) is an experiential learning event for learners to develop their knowledge and skills enabling them to critically evaluate a pharmaceutical supply chain system and improve their associated supervisory skills. The course encourages participants to make direct observations at the storage, warehousing, distribution and health care facilities that they visit as they physically travel with mentors by bus down the length of the supply chain. This approach is designed to show participants how the theoretical background of pharmaceutical supply chain management is applied in a variety of storage, distribution, and health care facilities. It is a practical application of experiential learning theory.

By the end of the 6-day event, the participants will be able to:

  • Identify the major operational components in a pharmaceutical supply chain
  • Identify deficiencies in given situations using the “good distribution practice” (GDP) guidelines
  • Illustrate the inputs, activities, and outputs of each operational component of a pharmaceutical supply chain
  • Develop a quality agreement that is appropriate to a given situation
  • Given a cold storage facility, assess and control the risks to pharma, biopharma, and vaccine products consistent with GDP and “good storage practice” (GSP) guidelines
  • Given a mode of transportation, assess and control the risks to pharma, biopharma, and vaccine products consistent with GDP
  • Given a mode of distribution in the “last mile”, assess and control the risks to pharma, biopharma, and vaccine products consistent with GDP
  • Given a situation, select the appropriate methods and materials for packaging and shipping cold chain products to avoid/minimize risk
  • Given a situation, select the appropriate methods and materials to monitor temperature and/or humidity for cold chain products to obtain necessary data for making quality decisions
  • Given a specific temperature monitoring strategy, assess and control the risks to pharma, biopharma, and vaccine products consistent with GDP/GSP
  • Examine and assess documents and records that support a cold-chain process consistent with GDP/GSP
  • Identify work practices that contribute or reduce risks to a cold-chain worker’s health and safety
  • Conduct the shake test to identify whether a given freeze-sensitive vaccine has been affected by freezing

 

WHO CAN APPLY?

TARGET AUDIENCE

The maximum number of participants for each course is set at 15.

Primary target audience

Representatives from the government sector involved in pharmaceutical cold chain in the areas of: regulation, inspection, planning and monitoring.

Representatives from the pharmaceutical/biopharmaceutical/vaccine industry in the areas of: Supply, packaging, distribution, logistics and cold chain management. Manufacturers who already supply WHO prequalified products are encouraged to participate.

Representatives from the equipment and device manufacturing industry in the areas of: Active cooling, passive cooling, temperature monitoring, and track and trace. Manufacturers who already supply WHO PQS prequalified products, or who wish to enter this market, are encouraged to participate.

Secondary target audience

Representatives from the pharmaceutical/biopharmaceutical/vaccine industry in the areas of: R&D, quality, regulatory, and manufacturing.

Representatives from WHO, UNICEF and other partner organizations: Technical officers responsible for pharmaceutical cold chain management activities at regional level, intercountry logisticians, health officers, EPI officers, and immunization advisers whose involvement in pharmaceutical cold chain is confirmed by their organizations.

Representatives from logistics providers.

Members of the faculty of institutions of higher education in health professions.

Independent consultants.

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