Risk Management in the Pharmaceutical Supply Chain

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Risk Management in the Pharmaceutical Supply Chain |

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Instructor : Hedley Rees Product Id : 600612 Overview: Supply chains for pharmaceutical products have become increasing complex as the industry has outsourced many non-core activities to third party contractors and sought lower prices for their materials around the global.

Duration: 90 Minutes

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Tuesday, December 13, 2011 10:00 AM PST | 01:00 PM EST

b Live live online training only for one participant c d e f g Price: $245.00

c Corporate Live 2 to 5 participants from a single d e f g

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location (For multiple locations contact Customer There are also many more players with stakes in avoiding supply chain failures, as licensing deals proliferate and investors place finance behind both emerging and mature companies in the sector. In this context, risk management means identifying potential risks across multiple stakeholders and disciples, under a whole range of risk areas with headings such as commercial, legal, technical, regulatory compliance and security. However, identifying the risks, although important, is only a part of the solution. The key ingredient is developing practical mitigations and executing on them through robust project and commercial plans. This repeating cycle of management of risk is explained using ICH Q9 recommendations as a basis for discussion. To achieve an appropriate level, the session takes a broad view of the end-to-end supply chain - how to map it and identify the typical ‘pressure points’ where issues and risk are likely to occur. The focus is on identifying the risks from multiple perspectives by achieving true cross-functional and crosscompany involvement and buy-in. The output from this becomes the input to a risk assessment exercise such as FMEA, the construction of which is explored.

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c Corporate Live 6 to 10 participants from a single d e f g Care)

Pack of THREE: Best Selling DHFDMR-DHR Webinars by GlobalCompliancePanel

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Price: $495.00

location (For multiple locations contact Customer

c Recorded Access recorded version only for one d e f g participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the

Customer Testimonials

completion of live webinar)

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

Price: $295.00

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The next stage of risk control is examined from a systemic perspective, whereby uncertainty and risk can be created by causal events or situations that are greatly removed from each other. For example, quality issues at a manufacturer can often be caused by their supplier’s supplier and mitigations would need to work upstream. There may also be corrective and preventative actions (CAPA) involved as part of the risk control planning; it may be necessary to engage the development team so that alternative materials are sought, process changes instigated or validation and verification undertaken. The final stage in the process is periodic review of the risk register to account for changes and new developments. This includes ways to institutionalize risk management into projects and business operations so that it becomes 'a way of life'. The concluding treatment of the topic covers supplies chain best practices that greatly enhance the likelihood of avoiding failure in the Pharmaceutical supply chain. Along with this is a perspective of what FDA and EMA/MHRA expect from the industry in response to their growing concern around supply chain issues and the upcoming regulatory changes. There will also be case study examples of how issues have been identified and mitigated during global launch and commercial sale of drugs. Why you should attend: The world is experiencing increasingly dysfunctional outcomes within end-to-end supply chains for pharmaceutical products. In response, FDA and regulators globally have placed improvement in supply chain integrity and product quality as an urgent priority. Key to meeting the rapidly escalating regulatory expectations is effective management of uncertainty and the associated risk of supply chain failure. Risk offers itself in many guises, for example, quality issues with a raw material that lead to product shortages, theft or counterfeiting of high value products and economically motivated adulteration of materials leading to patient death (eg Heparin, 2008). The over-riding message is that risk abounds in the supply chain and only properly structured and executed risk management approaches are likely to gain regulatory acceptance going forward. The International Conference on Harmonization has issued guidance on Risk Management (ICH Q9) which lays out the expectations for a structured Risk Management process and explains some of the tools such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Along with this however, it is vitally important to understand the specifics of how, when and where to apply the tools and how to get at the deeper organizational issues that often underpin supply chain risk; also, how to create the important upstream and downstream linkages that are so necessary to maintain security. Without a clear understanding of your business risk exposures in the supply chain and plans for managing those risks in a professional manner, it will become increasingly difficult to operate in the complex, interdependent pharmaceutical industry of the 21st century. Areas Covered In the Session: Risk assessment Risk control Risk review Typical supply chain risk areas

Price: $495.00

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but

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ICH Q9 Supply chain management (SCM) best practices Upcoming Regulatory changes Who will benefit: Preclinical Development Clinical Development Regulatory Affairs Quality Assurance Pharmacovigilance Purchasing Procurement Supply Management Operations Production Management Warehouse Management Import/export

Hedley Rees is a practicing consultant, coach and trainer, helping healthcare companies build, manage and continuously improve their clinical trial and commercial supply chains and risk profiles. He has his own company, Biotech PharmaFlow Ltd, based in the UK and handles assignments across the spectrum from top ten Pharma’s through to highly virtual early stage start ups. Prior to this, Hedley held senior supply chain positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of supply chain management processes from strategic procurement, production and inventory control, distribution logistics, information systems and improvement. His specific interest is in driving industry improvements through the regulatory modernization frameworks of FDAs 21st Century Modernization and ICH Q8 – Q10. Hedley holds an Executive MBA from Cranfield University School of Management and is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS). He is a member of the UK BioIndustry Association’s (BIA) Manufacturing Advisory Committee and also regularly speaks at international conferences, being co-chair of the 2011 FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati, October 2 -5. He has published in US and EU pharmaceutical journals and is author of “Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics” published by J. Wiley & Sons, Hoboken, New Jersey.

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