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Managing Technology Transfer Projects in Pharma

Sep 24 - Sep 25, 2020
Dublin, Ireland

  • 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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 24 September 2020

    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
    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

    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
    • Knowlegde Transfer Assessment

    17.15
    Q&A


    18:00

    End of Day 1

  • Friday, 25 September 2020

    9.00
    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

    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 Course

Trainers

Mirko  Gabriele
Mirko Gabriele
Thermo Fisher Scientific

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

    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
      • Regulatory Affairs Specialists

Got a Question? We have answers

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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.

Crowne Plaza Dublin Airport

Northwood Park
Dublin, Ireland
Phone: +353 1 862 8888

Crowne Plaza Dublin Airport
  • Accommodations

    Hotel Nearby
    PDA Europe recommends the reservation at one of the following hotel.
    The general terms of business are valid at the event hotels.


    Crowne Plaza Dublin Airport
    Northwood Park
    Santry Demesne
    Dublin 9

    The hotel is a 5-minute drive from Dublin Airport, with a free shuttle to and from the airport. It has luxurious rooms, free internet and good bus links to the city centre.
    Each bedroom has air conditioning, an on-demand movie system, a safe and ironing facility.Crowne Plaza Dublin Northwood is set in parkland, close to the M1 and M50, and 15 minutes from Dublin city centre.

    Northwood Crowne Plaza has a coffee bar, the Cinnabar Red Bar and a Californian-Asian restaurant, for a great variety of food and drinks. Breakfast starts early at 06:00. Crowne Plaza Northwood offers a park and fly facility and is on the airport bus route. Omni Shopping Centre, Swords Pavillions, Movie Plex and Northwood Business Campus are nearby. Croke Park Stadium is a short drive away.

    PDA Europe has reserved a limited number of rooms until the 24th July 2020
    Book your room for the PDA Group Rate

    • Single Superior Room € 159 per night*
    • Double Superior Room € 189 per night*

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport:

Dublin Airport - DUB
Airport Phone: +353 1 814 1111
9km , 10 min by car
Free Shuttle Bus fom and to the Hotels

By Car

The hotel is almost 10km away from the Dublin Airport.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro, excluding VAT (23%)


* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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