Initiation:

Identify a high-eod overview of the requirements, documents, and process flow map involved in the TT from the European-based pharmaceutical manufacturer to the third country sites 20°. outside of Europe for release and sale in the EU only: °

•  Sending and receiving site information required
• What does the new supply chain look like? What are the main documents that need to be in place to ensure a smooth initiation phase? What are the main areas of focus such as facilities? personnel, regulatory licenses, etc.
• e New supply chain map must be included

Planning: Discuss the potential gaps and risks in great detail and propose solutions to address these issues 30%

•  Detailing at least 3 possible gaps (Gap analysis) in the information package from the sending site and determining the criticality (Risk analysis) of the information gaps in the progression of the process development phase of the transfer
•  Propose solutions to address the gaps and risks in detailed
• Utilise references (such as Eudralex/ICH Guidelines) in providing a rationale for your decision