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2020 BioMan

PDA Europe Virtual Training Course - Managing Technology Transfer Projects in Pharma

Sep 29 - Sep 30, 2020
2:00 PM
-
5:00 PM
| Central Europe Standard Time
Online
  • Virtual
  • Education
  • Online
  • Europe

Overview

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.

Agenda

  • Day 1
  • Day 2
  • Tuesday, 29 September

    14:00
    Attendees Introduction and Course Expectations


    14:10
    Course Introduction


    14:15
    Pharma Management

    • What is a project in pharma? Main principles & final scope
    • Regulatory & Quality Framework
    • Pharma project lifecycle and main steps (Project Matrix)
    • Terminology

    15:00
    Team Role in Pharma

    • Org Chart approaches
    • Functions RACI in each single step

    15:30
    Project Management Role in Pharma Technology Transfer Projects

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

    16:00
    Pharma Tech Transfer Projects Governance

    • Governance standard approach in pharma
    • Project Governance Tools
    • Timelines definition
    • Planning and execution control tools
    • Performance indicators
    • Project Closure

    17:00

    End of Day 1

  • Wednesday, 30 September 2020

    14.00
    Case Study 1 (Technology Transfer from Development to Commercial)

    • Project Chart creation
    • Stakeholder Map definition
    • Costs and Business Case evaluation
    • Technology Transfer Timelines Principles and Gantt definition

    16.00
    Case Study 2 (Technology Transfer from Commercial to Commercial)

    • Performance KPI examples
    • Resources allocation
    • Technology Transfer Governance Principles
    • Project Closure and lesson learnt analysis

    17:00
    Q&A and End of Course

Trainers

Mirko  Gabriele
Mirko Gabriele
Thermo Fisher Scientific

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

Registration Fees

Register Now
Registration Type Price
All Participants €800

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