Conference Day Two
8:00 am - 9:30 am OPTIONAL ADD ON: DON'T FORGET TO BOOK
Market Search and the Emerging Markets
With increasing competition from generics, there is huge pressure on the industry to be able to manufacture at cheaper costs to maintain market dominance. But, how do you do this?
One solution is to look at manufacturing in the emerging markets. Not only can this help with scaibility and offer novel technologies, but also it can reduce your supply chain to certain regions around the globe. However, this is not a simple solution. Identifying partners with specific technologies is a challenge and technical support is needed to develop a robust manufacturing process. Not to mention issues with GMP compliance, regulations, and the most important factor – QUALITY.
Join this workshop to determine the best way to approach CMOs in the emerging markets, and understand how you can build this into your fundamental strategy for your cost improvement projects!
Roger CassidyManaging Partner
9:00 am - 9:30 am Registration and Welcome Coffee
9:30 am - 9:40 am Chairman's Summary of Day One
9:40 am - 10:20 am Case Study: Criteria to Select a CMO
• Discuss the desired goals and objectives of a new CMO, with an overview of the selection process
• Review the acceptance criteria for successful selection and tech transfer
• Specifically gain insight on the selection of a CMO for manufacturing HiPo DP, Low Volume Injectable
David CaronVP, CMC
10:20 am - 11:00 am Johnson & Johnson Digitilisation Approach to Transform its Supply Chain and Address Market Trend & Disruptors
· Look at building the future work force
· Review E2E supply chain governance management
· Evaluate collaboration with external manufacturers
Sultan AzizSenior Director, Product Supply Strategy Management
Johnson & Johnson
11:00 am - 11:30 am Enabling Operations Excellence for Contract Manufacturing – Using Advance Modeling and Data Science Techniques
- Look at retrofitting existing assets for new recipes
- Discuss asset selection, utilization and optimization
- Review profitability & safety using advanced analytics
Dr Mothivel MummudiGlobal Industry Director
Praveen KapseVice President, Global Strategy and Innovation
11:30 am - 12:00 pm Coffee Break
12:00 pm - 12:30 pm MMTS Minitab – From Product Design to Commercial Scale
• Discuss the significant unmet need to formulate medicines that are easy to administer to children to optimize acceptance, encourage adherence and improve health outcomes
• Review how Minitablets can be one of the solutions - also for patients with dysphagia, and when flexible dose adjustments is needed
• Identify the growing popularity of Minitablets thanks to recent guidelines and a growing understanding of children swallowing capability, but also because the manufacturing equipment used to produce Minitablet-based dosage forms are the same as those employed in manufacturing of standard tablet
• Understand the adjustments and optimization of the manufacturing processes and testing approaches that are required to secure efficiency, robustness, and productivity
Giuseppe De FranzaManager Continuous Improvement Italy
12:30 pm - 1:10 pm Case Study: CMO Management Process
• Identify how to base your internal structure to manage external relationships
• Discuss best practice and how this can be applied in your role
• Learn how to assess risk and how this can determine the network of partners you form
Glen PeaceSenior Director Operations - Global External Supply
1:10 pm - 2:10 pm Networking Lunch
2:10 pm - 2:25 pm Advantages for Patients and Industry – Innovative Dosage Forms from tesa
• Look at how a CDMO for films and patches can provide added value for pharma companies
• Specific case study insight into Mucofilm®Technology, Rapidfilm®Technology and Transfilm®Technology
• Approach from idea to market, by your side
Dr Timo TaghizadehDirector Business Development/Sales & Marketing
tesa Labtec GmbH
2:25 pm - 3:05 pm Supplier Risk Management: A Risk Based Oversight over CMO processes
• Employ tools to create risk assessment/management action plans
• Ensure operational risk management with CGMPs (Current Good Manufacturing Practice) regulations enforced by the FDA
• Engage CMOs in risk management activities
• Discuss Project Risk Management, Risk Management Planning, Monitoring and Controlling risk and Graphical and Quantitative Methods of Risk Monitoring and Reporting
Jayet MoonQuality Lead
3:05 pm - 3:45 pm Emerging Markets and the Impact on CMO/Sponsor Relationships - Russia and EAEU Case Study
• Get to grips with the regulatory basis for Russian HA site inspections and how to implement a risk based approach to resolve the situation
• Determine the impact on CMO manufacturing when GMP status isn’t granted
• Review the changes to expect from the EAEU GMP regulation being adopted and how to prepare
• Whose responsibility is this – the site or the sponsor?
Luba SkiboPrincipal Consultant
Skibo Regulatory Consulting
3:45 pm - 4:30 pm Interactive Troubleshooting Session
Back by popular demand!
As we all know, a crisis can arise anywhere - often leaving you with very little time to re-group and strategise. That’s why we’ve created an interactive session designed to put you on the spot! All delegates will form small groups and look to each other to work through a series of ‘crises’ you might encounter. Put on your thinking cap and prepare to get stuck into a team challenge!
Roger CassidyManaging Partner
4:30 pm - 5:00 pm End Your Conference With a Good Old-Fashioned Quiz!
Designed to test what you’ve learned over the course of the conference, each table is given an answer sheet and will be asked a series of PCM related questions.
Keep your sheets as a reference guide to take back to the office with you!