First Track

9:00 AM Essential GDP Compliance

With the need for key personnel to be fully aware of the key requirements of EU GDP Guidance, this short workshop looks at the Essential elements of GDP compliance including:
• An overview of the regulatory environment for logistics under EU343/01
• Quality Management – Key elements for implementation
• Training – Who needs what and developing a training matrix
• Documentation – Basic requirements of SOP’s and Quality Agreements
• Outsourced Activities
• Transportation – Risk Assessment and Thermal Solutions

Second Track

09:00 AM Make Your Data Work For You: Improving Your Temperature Controlled Supply Chain with Predictive Analysis Techniques

QA, logistics and cold chain professionals spend so much time working on data, it¡¦s time to have data work for you! Data collected along the temperature controlled supply chain holds the key to developing new profiles, conducting quality assessments and optimising supply chain performance. Use it to unlock increased efficiency in your supply chain.

Attend This Workshop and Learn to:
  • Develop best practices for managing deviations, performing investigations and implementing corrective and preventive actions
  • Mitigate the effects of human error on data management without compromising compliance and data integrity
  • Use data to go beyond archiving, searching, viewing, exporting temperature data and use it for developing risk-based profiles, conducting quality assessments and optimising supply chain performance
  • Hear practical examples and case studies to identify strategies to do this
  • Ensure you are maintaining GDP compliance while implementing new strategies
  • Evaluate various cost cut options and techniques

First Track

11:30 AM Switching to Sea Freight

Transporting pharma products by sea has countless advantages, from increased security and quality to lower costs. The shipping industry is ready to provide solutions for the pharma market, but are you ready to change your mode of transport? With the advantages come new challenges. In this interactive workshop you will develop ideas and strategies to address these challenges head on. With a smaller group it’s also your chance to bring your questions and discuss them with the group which will include people already successfully using sea freight and be lead by a workshop leader with extensive
expertise in this area.

Second Track

11:30 AM Capitalising on the Biologics Boom: Managing Temperature-Controlled Clinical Trial Supply Logistics

Building a successful logistics strategy for your clinical trial supply can be fraught with challenges, but the potential payoff is massive. Whether your clinical trial products are small or large molecule, the logistics surrounding your trials can have significant and ongoing impacts on your trial timeline and expenditure. Develop a functional and efficient strategy to transport your sensitive products and be ready to reap the financial rewards of the biologics boom.

Attend this workshop to:
  • Utilise the temperature data you collect to gain greater supply chain visibility and improve future processes
  • Use stability data for clinical shipment strategies including widening shipping ranges and using multi-level monitoring
  • Put in place preparations for new clinical trial regulations and develop best methods for creating a chain of custody
  • Ensure you are controlling and correcting problems zones in your global trial distributions, and make sure your couriers and CROs are too
  • Proactively improve your operations through clinical site evaluations
  • Implement strategies to handle all temperature ranges without using costly extra resources
  • Use real life case studies to discuss ways to handle all of the multitude of challenges in today's clinical supply chains

First Track

2:30 PM Thermal Mapping of Temperaure Sensitive Products: Risk Management and GDP Compliance

Chapters 3 and 9 of the GDP regulations state that it should be possible to demonstrate that medicines have not been exposed to conditions that may compromise their quality and integrity regardless how they are stored or transported, and that a risk-based approach should be utilised.
Temperature mapping is hereby pivotal to prove the capability of the storage and transportation systems, taking into account all possible anticipated variations and risks involved.

Attend this workshop and learn:
  • How to apply risk management in pharmaceutical warehousing and distribution
  • How to prove that your warehouses, vehicles and equipment are suitable for their use and provide adequate protection from external influences
  • How to qualify transportation systems to ensure correct transport conditions at all anticipated external temperature extremes, operational demands and transportation times. Can a “Family Approach” be used in order to accomplish this?

Second Track

2:30 PM Ambient Product Distribution

Distributing ambient products has always presented a challenge, and never more so than in the current changing global landscape of the pharmaceutical industry. Emerging markets and fields which are offering opportunities for the industry are presenting challenges for those involved with distributing the finished products. Distribution volumes are changing in line with clinical trial developments and regulations surrounding temperature controlled products are tightening. The longer distances which products have to travel inevitably leads to a more complex network, increasing the chances of a failure in processes be it technical or human. Although each market has slightly different requirements, the
essentials remain the same: pharmaceutical companies must have methods in place to ensure the products meet the end user without having experienced a temperature breach.

Attend this workshop to:

  • Discover new technologies that can make the process of temperature monitoring and the creation of temperature profiles more sophisticated
  • Learn how more than 15 countries worldwide are now able to identify heat damage before the product is administered to the patient using cumulative heat monitoring devices attached to each unit of medicine
  • Develop strategies to overcome challenges around regulators pushing for more stringent monitoring regulations than those currently laid out in guidance, including a requirement for continuous temperature monitoring, which will place more pressure on distribution channels
  • Ensure you are achieving best practice end to end distribution within the World Health Organisation's Model Requirements For The Storage And Transport Of Time And Temperature Sensitive Pharmaceutical Products
  • Address security challenges and risks of product diversion
  • Select the right packaging which can ensure products remain within the correct temperature range throughout the journey will reduce the risks associated between transferring between modes of transport