PDA EU00160 Managing Technology Transfer Projects in Pharma
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Significant changes must be handled daily in the dynamic world of pharmaceutical production. A continuous improvement of regulatory and quality frameworks is only one of many reasons. More than 160BN US Dollars were 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. A huge growth in CDMO business was experienced in the last years and is further foreseen in the next years. Due to these and more reasons 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, clinical, and commercial manufacturing.
Moreover, matrix organization is becoming a key approach to provide agility and scalability and ensure efficacy. The combination of the above aspects and the strict combination of Technology Transfer with Project Management concludes that project management skills, tools, and expertise are must-haves and key drivers for success. Project management needs to be customized to the unique environment of the pharmaceutical industry!
The PDA Managing Technology Transfer Projects in Pharma training course will help you to understand the opportunities project management in pharma can offer and how to apply these skills and tools most efficiently.
Who Should Attend
Project Managers and Technology Transfer Managers
Subject matter experts involved in Technology Transfer and coming from different areas such as:
- Analytical SME
- Production SME
- Qualification/Validation SME
- Qualified Persons
- Responsible Persons
- Regulatory Affairs SME
- Other stakeholders involved in Technology Transfer Projects
Learning Objectives
Upon completion of this course, attendees will be able to:
- Understand the principles, main documents, and main steps of a technology transfer process (internal and external
- Understand Project Management tools specific to pharma technology transfer projects
- Identify and mitigate risks in technology transfer processes
- Understand the main roles and responsibilities of the stakeholders of the technology transfer process
- Manage project changes
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Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
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Day 1
Thursday, 26 September 2024
9:00
Attendees' Introduction and Course Expectations
9:15
Course Introduction
9:30
Technology Transfer Pharma Project Management
- Introduction to Technology Transfer
- What is a Technology Transfer 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 and activities
- Risks and mitigation in goal achievement
12:00
Project Management Role in Pharma Technology Transfer Projects
- Technology Transfer as key example of a 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's main principles
- Performance indicators
- Lesson learned
- Project closure
Breakout: Pharma TT project 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 have to leverage change management to mitigate those risks
17:15
Q&A
18:00
End of Training Course Day 1
Day 2
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 on 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
Featured Trainers
-
Angela Molaschi
Pharmatex Italia Srl/Fisiopharma Srl
Read 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.
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