- GMP and Compliance
- Pharmaceutical Product Development
- Pharmaceutical Manufacturing Support
- Development and Manufacture of Effervescent Tablets
- Hands-on Tablet Development including the principles of pre-formulation, formulation and process dev
- Introduction to Sterile Product Manufacture for New Starters and Junior Staff
- Introduction to Sterile Product Manufacture for those with a cGMP basic understanding
- Oral Solid Dosage Manufacturing Technology
- Pharmaceutical Packaging - an introductory course
- Planning for Commercial Launch
- Stability Testing in Biological Product Development and Manufacturing
- Supply Chain Management in Pharma/Biotech
- Supply Chain Risk Management and Compliance for QPs and RPs
- Technology Transfer
- Pharmaceutical R&D Support
- In-house Training Courses
Planning for Commercial Launch
No Course Dates Currently Available
Overview
This two day workshop aims to provide participants with the knowledge and simple processes required to plan for launch of pharmaceutical and biopharmaceutical products in global markets. It is designed specifically for those involved at the drug development/commercial supply chain interface. This is a critical area where actions and risk mitigations must be carried out cross-functionally so that launch objectives and deadlines can be consistently met. The course is equally applicable to innovator and out of patent (generic/biosimilars) sectors.
Participants will learn how to:
- Engage relevant stakeholders in launch preparations
- Map the current state supply chain and information flows
- Identify and resolve potential supply chain issues prior to registration
- Develop and/or contribute to clear, detailed future state supply chains and control plans
- Use simple material requirements planning and master scheduling through the end-to-end supply chain
- Create inventory visibility and pedigree
- Manage change simply, effectively and compliantly
- Interactive case studies where participants learn by doing
- Best practice aspects of strategic procurement, material planning and logistics
- Advice on the softer side of building relationships with key stakeholders in the launch process
- An innovative check list to ensure all supply chain aspects are pulled together in an integrated, inclusive fashion.
Who Should Attend?
Those either directly responsible for planning and delivering commercial launch of products or involved in teams charged with that responsibility, including:
Managers and practitioners in supply chain management
- Demand/supply planning
- Logistics
- Procurement
- Inventory management
Managers and practitioners in Clinical Trial Supply
- CTS and packaging groups
- Clinical operations
- CMC (pharm tech/chem./biochem)
- Analytical Chemists
Managers and practitioners in related disciplines
- Project Management
- Production
- Quality
- Regulatory affairs
- Marketing
- Finance
- Business development
Course Programme
Questions and answers will be taken throughout the duration ofthe course.
Day 1 8.30 Registration and Coffee
Day 1 - 9.00 Morning session
- Mapping the current state supply chain
- Defining supply chain business process maturity
- Modelling uncertainty
- Completing the risk assessment
- Case study exercise
- Review of day 1
Day 1 - Afternoon session
- Mapping the current state supply chain
- Defining supply chain business process maturity
- Modelling uncertainty
- Completing the risk assessment
- Case study exercise
- Review of day 1
Day 2 - Morning session
- Mapping the current state supply chain
- Defining supply chain business process maturity
- Modelling uncertainty
- Completing the risk assessment
- Case study exercise
- Review of day 1
Day 2 - Afternoon session
- Aligning and deploying resources
- Keeping things on track up to launch
- Executing on peri and post launch activities
- Capturing learning for next time
- Case study exercise
- Review of day 2 and close.
17.00 Close of course








