PDA EU00160 Managing Technology Transfer Projects in Pharma

Gothenburg, Sweden
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In the dynamic world, pharma-significant changes need to be handled daily. 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 and ensure efficacy. The combination of the above aspects concludes that project management 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 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.

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

Learning Objectives

Upon completion of this course, attendees will be able to:

  • Understand the principles, main documents, and main steps of a technology transfer process (internal and external
  • Understand Project Management tools specific to pharma technology transfer projects
  • Identify and mitigate risks in technology transfer processes
  • Understand the main roles and responsibilities of the stakeholders of the technology transfer process
  • Manage project changes

Standard Pricing

Standard Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

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

Day 2

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

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotel

Elite Park Avenue Hotel 
Kungsportsavenyn 36 - 38
411 36 Gothenburg,
Sweden

PDA Europe has reserved a limited number of rooms until the 20th July 2024.

Book your room at the PDA Group Rate via the above-mentioned reservation button.

How to Get Here
By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Gothenburg Berzeliigatan. They run directly between these stops.

Unlock discounted pricing with the following code DEAPILQ and simply use the provided link below.
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