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2023 PDA_Training-1988x680

PDA EU00160 Managing Technology Transfer Projects in Pharma

Sep 26 - Sep 27, 2024
Gothenburg, Sweden

  • Education
  • Europe


In the dynamic world of pharma significant changes need to be handled on a daily basis. A continuous improvement of regulatory and quality frameworks is only one of many reasons. More than 160BN US Dollars will be invested in R&D until 2020 according to most recent  trends. Novel active compounds need to be identified and an increased activity in M&A is foreseen with a few big players sharing the market. More Technology Transfer Projects are expected to be executed to respond efficiently and rapidly to the needs of “process mobility” in the field of R&D and manufacturing. Moreover, matrix organization is becoming a key approach to provide agility and scalability to the organization and to ensure efficacy. The combination of the above aspects draws the conclusion that project managements skills, tools and expertise are a must- have and key drivers for success. Project management needs to be customized to the unique environment of the pharmaceutical industry!

The PDA Europe Managing of Tech Transfer Projects in Pharma course will help you to understand the opportunities project management in pharma can offer and how to apply these skills and tools most efficiently.


  • Day 1
  • Day 2
  • Thursday, 26 September 2024

    9:00 Attendees Introduction and Course Expectations

    9:15 Course Introduction

    9:30 Technology Transfer Pharma Project Management

    • What is a project in pharma? Main principles & final scope
    • Regulatory & quality framework
    • Pharma project lifecycle and main steps (project matrix)
    • Types of TTs
    • Business and Innovation Strategy
    • Terminology
    Breakout: Provide the framework where pharma technology transfer takes place with reference to most common used terms and TT aspects

    10:50 Coffee Break

    11:05 Team Role in Pharma

    • Org Chart approaches
    • Stakeholders map analysis and main team dynamic principles
    • Functions RACI in each single step
    • Project stages, activities and deliverables per single steps
    • Risks and mitigation in goals achievement

    12:00 Project Management Role in Pharma Technology Transfer Projects

    • Technology Transfer as key example of pharma project
    • TT Team RACI
    • Skills
    • Leadership styles

    Breakout: We will learn how to navigate in a pharma technology transfer space, focusing on the key actors and how they interact to succeed

    13:00 Lunch Break

    14:00 Pharma Tech Transfer Projects Governance

    • Governance standard approach in pharma
    • Project governance tools
    • Timelines definition
    • Planning and execution control tools
    • Resources allocation main principles
    • Performance indicators
    • Lesson learnt
    • Project closure

    Breakout: Pharma TT project clearly is a complex project, we will learn the fundamental tools to be used to govern it and boost it

    15:45 Coffee Break

    16:00 Pharma Tech Transfer Projects Risk Management

    • Risk Management in pharma principles
    • Risk Management tools

    16.45 Change Management

    • Project change
    • Change management process
    • Change management plan
    • Knowledge transfer assessment

    Breakout: At the end of this section you will have a clear understanding of the risk management applied to pharma TT and hove to leverage change management to mitigate those risks

    17:15 Q&A

    18:00 End of Training Course Day 1

  • Friday, 27 September 2024

    9:00 Case Study 1 (Technology Transfer from Development to Commercial)

    • Project chart creation
    • Stakeholder map definition
    • Costs and business case evaluation
    • Technology Transfer timeline principles and Gantt definition

    10:45 Coffee Break

    11:00 Case Study 1 (Technology Transfer from Development to Commercial) – Cont.

    12:30 Lunch Break

    13:30 Case Study 2 (Technology Transfer from Commercial to Commercial)

    • Performance KPI examples
    • Resources allocation
    • Technology Transfer governance principles
    • Project Closure and lesson learnt analysis

    Breakout: At the end of this second day, we will have applied tools and concepts explained in day 1 in a real technology transfer project. We will start together defining the framework and as a team we will define timelines, assign roles, calculate allocation of resources, identify and quantify risks and build a contingency plan to mitigate those risks.

    15:30 Q&A

    16:00 End of Training Course


Angela Molaschi
Angela Molaschi
Pharmatex Italia Srl/Fisiopharma Srl

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants

    • Understand principles, main documents and main steps of a technology transfer process (internal and external
    • Understand Project Management tools specific for pharma technology transfer projects
    • Identify and mitigate risks in technology transfer processes
    • Understand main roles and responsibilities of the stakeholders of technology transfer process
    • Manage project changes
  • Who Should Attend
    • Project Managers and Technology Transfer Managers
    • Subject matter experts coming from different areas such as
      • Qualification/Validation Engineers
      • Qualified Persons
      • Responsible Persons
      • Security Specialists
      • Regulatory Affairs Specialists

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Gothenburg, Sweden

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Regular Price
Registration Type Price
All Participants € 2.090

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