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2019 PM

Managing Technology Transfer Projects in Pharma

Sep 03 - Sep 04, 2019
Munich, Germany

  • 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
  • Tuesday, 3 September 2019

    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

    15:30
    Pharma Tech Transfer Projects Risk Management

    • Risk Management in pharma principles
    • Risk Management Tools

    16.30
    Change Management

    • Project Change
    • Change Management Process
    • Change Management Plan

    17.00
    Q&A


    17:30
    End of Day 1

  • Wednesday, 4 September 2019

    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 are key
    • Subject matter experts coming from different areas such as
      • Production
      • QA
      • Validation
      • Engineering (involved in process/equipment design)
      • RA
      • QC (involved in analytical transfer
  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Sheraton Munich Arabellapark Hotel

Arabellastrasse 5
Munich, Germany
Phone: +49 (0)89 92320

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 7th July 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 169 per night* 
    Double Room € 194 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 will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone:
+49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

* 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.

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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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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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