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Supply Chain Management in Pharma and Biotech

Course Dates:  3 & 4 December 2009            

Venue: Window Conference Venue, Islington London UK

Cost: £1160.00 + £174.00 VAT (Total £1334.00)

Speaker - Hedley Rees Managing Director of PharmaFlow Ltd

Historically in pharmaceuticals, performance of the supply chain has been a low priority. Cushioned by blockbuster drugs with secure markets and ‘very healthy’ margins, main emphasis was placed on the scientific and technical aspect of registration and supply. So long as the drug was approved and patients received the drug manufactured to the regulators satisfaction, then job done.

We all know now the bar is being raised to a previously unimagined level. The global pressure to contain healthcare budgets is focussing on prescription medicine, which in turn spotlights the cost, quality and reliability of drug manufacture and supply.

The current modernisation initiatives such as PAT, QdD and ICH Q9, for example, provide evidence that the regulators are throwing down the gauntlet.

In response, pharma is moving supply-chain centre stage, in an attempt to build supply-chains comparable with exemplar sectors such as aerospace, semi-conductor and automotives,

Course Description

This 2-day workshop aims to provide participants with a complete overview of professional supply chain management processes used across all sectors and then spotlight the issues and opportunities that exist specifically within pharmaceuticals.

The format of the workshop will be interactive, using case study exercises. Participants will be encouraged to bring along any burning questions that exist within their organisations for discussion (whilst maintaining confidentiality).

Just some of the benefits to be derived from this workshop include:

•  Vastly increased value delivery from CRO’s and CMO’s and other service providers.
• Focus on the actions that can transform supply-chain performance.
• Reduced risk of delays and failure in getting drug to site or channel.
• Stronger and tighter third party relationships and agreements.
• Enhanced control of inventory investment, availability and traceability.
• Ability to perform risk assessments and mitigation plans for the supply network.
• Appreciation of how to build shared understanding of CMC activities within project management teams.
• Increased confidence in driving continuous improvement through your supply chains.

The course will start with coffee and registration at 8.30am, course proper will start at 9.00am

• Who should attend?
• Staff wishing to understand how effective supply chain management can contribute significant benefits to an organisation.
• This would include Project Managers, Clinical and Non-Clinical project team members, Contract Managers, Quality and Compliance, Finance, Regulatory Affairs, Marketing and Business Development.

 

Programme

  Procurement

• Segmenting the portfolio
• Source planning
• Procurement cycle
• Gathering supply market intelligence
• Tendering – ITT/RFP/RFQ
• Supplier conditioning
• Supply/Service Level Agreements
• Relationship maintenance

  Demand Supply Planning

• Current state mapping
• Envelope of uncertainty
• Demand forecasting
• Master planning
• Production scheduling
• Material Requirements Planning (MRP I)
• Manufacturing Resource Planning (MRP II)
• Capacity planning
• Sales and Operations Planning (S&OP)
• Enterprise Resource Planning (ERP) Systems

  Inventory Management and Control

• Defining inventory policy
• Creating inventory records
• Inventory record accuracy
• Forward/reverse traceability
• Expiry/re-test dating
• Shelf life supporting stability data
• Managing excess/obsolete
• Material change control

  Distribution Logistics

• Third party logistics providers (3PL’s)
• Modes of transport
• Incoterms (2000)
• HM Customs duty and clearance
• Commodity coding
• Channel management
• Parallel imports
• Anti-counterfeiting     

  Continuous Improvement

• 5S
• Lean (TPS)
• Kaizen and Kaizen blitz
• Process/operational excellence
• Six sigma DMAIIC
• Single Minute Exchange of Die (SMED)
• Quality by Design (QbD)
• Process Analytical Technology (PAT)

  Bringing it all together

• Identifying stakeholders
• Listening to Voice of the Customer (VoC)
• Defining Critical to Quality Attributes (CTQ’s)
• Creating ‘one shared view’
• Analysing the current state map
• ‘Seeing the whole’
• Deciding architecture and reach
• Agreeing target and future states
• Developing a control plan
• Gaining organisational buy-in

Speaker:

Hedley Rees, Managing Director of Pharmaflow Ltd .

Hedley has had many years in the pharma and biotech industry working with high profile biotech and emerging specialty pharmaceutical companies to bring new Molecular entities and re-profiled compounds through development stages into full scale commercial launch.  He has been a key contributor to trial progression and commercial launch across all phases of development in multiple territories and global markets.

Previously Hedley was responsible for managing global supply chains in big pharma companies such as Bayer and Johnson & Johnson.  Here, he built a wide competency base in all the disciplines of supply chain management, implementing and using state-of-the-art information systems enablement.   He holds an Executive Master's in Business Administration from Cranfield University School of Management, a degree in production and industrial engineering from the University of Wales and is a full corporate member of the Chartered Institute of Purchasing and Supply (CIPS).  Currently, Hedley sits on the Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.