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PDA EU00160 Managing Technology Transfer Projects in Pharma

Sep 22 - Sep 23, 2022
Amsterdam, The Netherlands

  • 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, 22 September 2022

    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, 23 September 2022

    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

Angela Molaschi
Angela Molaschi
Pharmatex Italia Srl/Fisiopharma Srl
Bio
Angela Molaschi
Pharmatex Italia Srl/Fisiopharma Srl

Angela Molaschi is Business Development Manager for Pharmatex Italia Srl and Fisiopharma Srl, two italian companies focused on development, production and commercialization of injectable drugs. In her current role Angela is responsible of the Business Development activities, including international customers management, new opportunities evaluation, commercial discussions and contracts, project management and technology transfer activities, CDMO business, in-licensing and out-licensing of products. Angela started her career in 2004 in Nerviano (MI), Italy, in a Pfizer production plant dedicated to injectables manufacturing, where she covered different roles in Six Sigma/Ops Excellence, Regulatory Compliance and Quality Assurance until 2008 when she started working in Technology Transfer. From 2008 to 2018 Angela acted as Technology Transfer and New Projects Leader taking care of introduction of new products and new technologies in Nerviano production plan, then acquired by Actavis/Teva and covering roles if increased responsibilities until becoming responsible of New Projects Introduction department. In 2018 Angela left Teva and joined an italian B2B company, NTC, as Technical Operations Manager, responsible of the outsourcing activities and CDMOs management. In 2020 Angela left NTC to join her current company.

Through the years Angela developed a great expertise in Technology Transfer and is leading training courses on this topic since several years.

She has a degree in "Pharmaceutical Biotechnology" at the University of Milan, Italy, Executive Master in Project Management at "Sole 24 Ore Business School", Milan, Italy, EMBA attendee at LIUC Business School, Castellanza (VA), Italy.

In addition to that Angela cooperates actively with PDA EU and PDA Italy for which she acted as President from 2017 to 2021.

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.

Hilton Amsterdam

Apollolaan 138
Amsterdam, The Netherlands

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Hilton Amsterdam
  • Accommodations

    Rate: Single Room € 219 per night*
    Rate: Double Room € 239 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

    Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 01 July 2022.

    Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum.

    The hotel does not have a shuttle bus

    There are several options for transportation from Schiphol Airport to the hotel. Schiphol is 15KM away from the hotel, and Rotterdam 65KM.

    Limo-service

    The hotel can arrange a private driver to pick you (and fellow travellers) up. The driver will be waiting for you after luggage pick up. The price for this service is 95 euro for a sedan, 110 euro for a mini-van. If you would like to use this service, please inform the hotel at least a few days in advance.

    Car-Sharing (App & membership required)

    Sixt share cares are available at the airport and their entire fleet is hybrid. Follow the signs ‘car rental’ from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Choose your favorite car , register it on your SIXT app and exit the parking garage.

How to Get Here

By Air

The international airport of Amsterdam is "Schiphol" located 15 km away from the hotel and conference space.

By Car

Parking is available on site, € 45.00 per day. No valid parking.

Other Options

Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). From there you can either walk for approximately 15 minutes or take tram Nr. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. From the tram stop it is about 5 minutes walking to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.795

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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