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2023 PDA_Training-1988x680

PDA EU00160 Managing Technology Transfer Projects in Pharma

Sep 14 - Sep 15, 2023
Seville, Spain

  • Education
  • Europe
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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.

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Agenda

  • Day 1
  • Day 2

  • Thursday, 14September 2023

    9:00 Attendees Introduction and Course Expectations

    9:15 Course Introduction

    9:30 Pharma Management

    • What is a project in pharma? Main principles & final scope
    • Regulatory & quality framework
    • Pharma project lifecycle and main steps (project matrix)
    • Terminology

    10:30 Coffee Break

    11:00 Team Role in Pharma

    • Org Chart approaches
    • Stakeholders map analysis and main team dynamic principles
    • Functions RACI in each single step

    12:00 Project Management Role in Pharma Technology Transfer Projects

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

    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

    15:30 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

    17.15 Q&A

    18:00 End of Traning Course Day 1

  • Friday, 15 September 2023

    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

    10:30 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

    15.30 Q&A

    16:00 End of Training Course

Trainers

Mirko Gabriele
Mirko Gabriele
ThermoFisher Scientific
Bio
Mirko Gabriele
ThermoFisher Scientific
Mirko Gabriele is currently the Sr Director, Global Sterile Strategy Technology And Innovation of the ThermoFisher Scientific. Mirko started his career in Quality Control as team leader and supervisor, he held then, the position of R&D Chemist working on new entities synthesis and analytical development. In 2008 he joined Patheon, Ferentino site as Technology Transfer Project Manager. In 2010 he joined the Business team as Business Manager, dealing with contract negotiation, budget and Client relationship. In 2012 he was Technology Transfer Manager controlling manufacturig site porfolio, then Global Technology Transfer covering TTs on the 11 NA and EU sites. Latest role in operations as Technical Operations Director. He has 17+ year of experience in pharma, with experiences in API and Finished Product. Mirko has a degree in Pharmaceutical Chemistry, an executive MBA and a PhD. He is QP as well. He collaborates with PDA since 2010. In 2014 he led the PMCO task force issuing the TR 65 on ; since September 2012 he is member of the PDA RAQAB and reviewer for PDA Letter Committee. Funder and Co-leader of the Interest Group on TT since August 2015 and PDA European Trainer in TT.

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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Travel

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.

Melia Lebreros

C. Luis de Morales, 2
Seville, Spain
Phone: +34 954 57 94 00

  • Accommodations

    PDA recommends the reservation at the following hotel

    Melia Lebreros
    C. Luis de Morales, 2
    41018 Seville
    Spain

    Tel: +34 954 57 94 00

    PDA Europe has reserved a limited number of rooms by 01 August 2023.

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

  • Amenities

    The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.

How to Get Here

By Air

The hotel is only 8 kilometers away from Seville International Airport.

By Car

On site parking is available. Please contact the hotel for more information.

Other Options

Only 30 minutes by train from the airport to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.895

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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