\"

Day 2

08:00 AM Registration & Networking Coffee

08:45 AM Chairman’s Recap of Day 1

09:00 AM REGULATORY KEYNOTE: Welcome to the UK-The MHRA Present Inspection Enforcements and Standards

  • The MHRA's regulations and inspection expectations around Good Distribution Practice requirements in temperature controlled logistics
  • Discover the most common errors that MHRA inspectors encounter, and find out if you're guilty of them!
  • Develop strategies to ensure you pass your inspections first time, every time

9:30 AM How to Use Your 3PL Partnership To Thrive In a Changing Healthcare Landscape

  • Analyse the shifting regulations and changing market trends affecting today's temperature controlled supply chain
  • Decipher how supply chain best practices can make companies more agile and adaptable to improve efficiencies
  • Determine how to leveraging 3PLs to streamline and optimise your supply chain

10:00 AM IoT in the Commercial Supply Chain

10:30 AM Networking Coffee Break and Continuation of Top-Deck Innovation Sessions

STREAM A: Temperature Control and Quality Assurance

11:10 AM INERACTIVE CASE STUDY: Risk Assessments for New Transportation Route

  • Get involved in a discourse on risk assessment, particularly using temperature data for future planning

STREAM A: Temperature Control and Quality Assurance

11:45 AM Passive vs Active: A Guide to Decision Making

  • Gain in depth insight in to the differences, advantages and disadvantages between passive and active containers
  • Learn how different approaches are handled when merging the supply chain activities of 2 companies (GSK Vaccines and Novartis Vaccines)
  • Develop strategies to select the right container type for your business needs


STREAM A: Temperature Control and Quality Assurance

12:20 PM Preparing Your Serialization Network and Tools to Meet the 2019 FMD Requirements

  • Address key considerations for achieving FMD serialisation and Track and Trace compliance
  • Future proof your serialization and track and trace strategies and engage with your peers on their biggest serialization hurdles and how they overcame them
  • Align stakeholder responsibilities for the future and discuss how to manage different partner requirements in serialization
  • Discuss ways to bridge the gap between IT and the pharma production line
  • Assess ways to get the most out of your serialization strategy in terms of resource, compliance and ROI


STREAM B: Risk Analysis

11:10 AM BREAKOUT - CLEAN SLATE SESSION - A RISK BASED APPROACH

This interactive session will give you a hands on experience of applying SWOT and STEP analysis to a practical situation. Part 1 - A Brief Introduction to SWOT and STEP/PEST Analysis and How to Use Them as Part of your Risk Assessment Part 2 - Breakout Session – A Risk Based Approach You have to get your product from Frankfurt to Tanzania. In your tables - map out your 10 stage approach with no current per-conceptions of the restrictions you currently have with your supply chain. How will you map out your suppliers, who and how will you validate them? The groups will have 20 minutes to put together a group analysis and 20 minutes to compare and contrast their output to learn from the different approaches.

STREAM B: Risk Analysis

12:20 PM Assessing the Security Risk of Temperature Controlled Shipments of Pharma Products

Henry Moran, Chief Operating Officer, ASC Associates (Pharmaceutical Logistics)
  • Compliant Cool chain management is vital for efficacy and safety when shipping temperature sensitive pharmaceutical or healthcare products, but also is the security of the supply chain
  • Look into how to conduct global audits that ensure compliance to Good Distribution Practice (GDP) but also the Falsified Medicines Directive (FMD) focusing on a secure supply chain.
  • Understand: What are the risks? How do we mitigate them? What global intelligence resources are there and how can they help us build a robust secure supply chain?

img

Henry Moran

Chief Operating Officer
ASC Associates (Pharmaceutical Logistics)

STREAM C: Emerging Markets and Supply Chain Security

11:10 AM A Middle Eastern Regulatory Perspective

  • Gain insight into the cold chain and ambient supply chain regulations in the Middle East
  • Discover what you need to do to ensure speedy and efficient compliance in ME countries
  • Develop techniques to circumvent bureaucratic difficulties

STREAM C: Emerging Markets and Supply Chain Security

2:30 PM Entering Russia's Markets

  • Gain insight into the most recent tendencies of the Russian pharmaceutical market
  • Better understand Russian regulatory requirements and how to comply with them
  • Determine how to identify and work with the right partners to increase your chances of commercial success in Russia
  • Learn about customs clearance in Russia and connected risks

STREAM C: Emerging Markets and Supply Chain Security

4:15 PM Emerging Market Round Tables

If you want to do business in Latin America, Asia, the Middle East or parts of Eastern Europe you’re going to encounter
challenges! Our Emerging Markets Round Tables are each facilitated by an industry professional who has experience with the ins and outs of these challenging regions. Choose the round table on the region you most want to find out more about, and get
stuck into some serious discussions about doing business in these markets!
  • Table 1 – Asia
  • Table 2 – Africa
  • Table 3 – Latin America
  • Table 4 – Middle East
  • Table 5 – Eastern Europe

1:10 PM Networking Lunch and Continuation of Top-Deck Innovation Sessions

2:00 PM Shipping at Lane Capability and Lane Improvement Based on Enhanced Data Management

  • Hear an exclusive presentation on MSD's newly approved shipping strategy, which has yet to be presented on in Europe!
  • Decipher the main elements of that strategy, including lane capability and lane improvement programme
  • Identify the role that data management plays in the new strategy, and how it can progress your own shipping strategy

2:30 PM US PHARMCOPEIA UPDATE: The Past, The Present and Future of General Chapters, Packaging and Distribution- The New General Chapter on Storage and Distribution of Investigational Drug Product

As the pharmaceutical supply chain grows increasingly complex, and the risks to drug quality and safety correspondingly proliferate, more attention and resources are being focused on securing the materials and assuring their authenticity and integrity as they make their way through the supply chain. The U.S. Pharmacopeial Convention (USP) has developed a new General Chapter <1079.1> Storage and Transportation of Investigational Drug Products. The chapter is informational and offers recommended best practices for industry to help ensure the integrity of investigational drug products. This presentation will provide an overview of USP's general chapter development and revision process, the new general chapter in development and how regulatory agencies work to address risk associated with investigational drug products
  • Gain knowledge of USP's general chapter development and revision process
  • Learn about the new general chapter <1079.1> relating to investigational drug products.
  • Trace the history of storage and distribution controls that govern investigational drug products
  • Receive an update on chapter <1083>
  • Hear about future areas to be addressed by the Packaging and Distribution Expert Committee


3:00 PM Awards handed out to prize winners - make sure you're there in case one of these prizes has your name on it!

3:10 PM Networking Afternoon Tea and Top-Deck Innovation Sessions Continue

3:40 PM Healthcare Standards and Regulations: a GS1 Perspective

4:10 PM Achieving End-to-End Visibility with Strategic Engagement Across the Supply Chain

  • Ensure coverage of all weak points along the temperature controlled supply chain by employing the right partners for your specific requirements
  • Strategise on convincing Third Party Handling Agents to Invest in GDP
  • Develop strategies to determine who is liable for what aspect of the temperature controlled supply chain to ensure all contingencies are covered
  • Understand local compliance and clearing potential risks to select the right partners to help in the right regions
  • Manage your partnerships continuously with effective management strategies

4:40 PM Chair’s Closing Remarks and End of Main Conference