Skip To The Main Content
2023 PDA_Training-1988x680

PDA EU00160 Managing Technology Transfer Projects in Pharma

Sep 26 - Sep 27, 2024
Gothenburg, Sweden

  • Education
  • Europe
Coming Soon

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.

Ask a Question

Agenda

  • Day 1
  • Day 2

  • 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

  • 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

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

Got a Question? We have answers

Contact Us

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.


Gothenburg, Sweden

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 2.090

* 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].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially