PDA EU00160 Managing Technology Transfer Projects in Pharma
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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.
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
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Standard Pricing
Standard Member Price
€ 1.795GovernmentMember Only
€ 1.795
Health AuthorityMember Only
€ 1.795
Early Career ProfessionalMember Only
€ 1.795
StudentMember Only
€ 1.795
AcademicMember Only
€ 1.795
Non-Member
€ 1.795
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Thursday, 22 September 2022
9:00 Attendees Introduction
9:15 PDA Overview, Course Introduction and Expectations
9:45 Technology Transfer in Pharma Part I
- What is a project in pharma? Main principles & final scope
- Terminology
- Types of TTs
- Main aspects of Technology Transfer and success key factors: technical and organizational aspects
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 Technology Transfer in Pharma Part II
- • Regulatory & quality framework
• Pharma project lifecycle and main steps
• GMP aspects of Technology Transfer
12:00 Team Role in Pharma
- Team setting and organizational aspects
- Org Chart approaches
- Functions RACI in each single step
Stakeholders' Analysis Part I - Stakeholders map analysis and main team dynamic principles
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 Stakeholders' Analysis Part II
- Excercise
Project Management Technology Transfer Projects
• PM role in Technology Transfer
• TT Team RACI
• Skills
• Leadership stylesBreakout: In Pharma TT people have a crucial role. We will understand better stakeholders' roles, behaviors and management and role of the PM
15:45 Coffee Break
16:00 Pharma Tech Transfer Projects Governance
- Governance standard approach in pharma
- Project governance tools
- Timelines definition
- Planning and execution control tools
- Resources allocation main principles
- Lesson learnt
- Project closure
- Focus on CDMO Technology Transfer
Pharma Tech Transfer Projects Risk Management
• Risk Management in pharma principles
• Risk Management tools
Breakout: Pharma TT project clearly is a complex project; we will learn the fundamental tools to be used to govern it and boost it.
17.15 Q&A
18:00 End of Traning Course Day 1
Day 2
Friday, 23 September 2022
9.00 Pharma Tech Transfer Projects Risk Management
- Exercise
Change Management
• Project change
• Change management process
• Change management plan
• Knowledge transfer assessmentBreakout: Risk and changes management are fundamental aspects of the Technology Transfer. In this session we will learn how to handle them in a structured and effective way
10:45 Coffee Break
11:00 Case Studies
Breakout: Real examples of Technology Transfers
12.30 Lunch Break
13.30 Technology Transfer Workshops
• Project chart creation
• Stakeholder map definition
• Costs and business case evaluation
• Technology Transfer timeline principles and Gantt definition
Focused A: Technology Transfer from Development to Commercial
Focused B: Technology Transfer from Commercial to Commercial
Conclusions and take away
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
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Request InformationPLEASE 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.
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.
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.