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
Agenda
Discover What's Happening Each Day
Thursday, 14 September 2023
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
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, 15 September 2023
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
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Venue Details and Accommodations
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.
PDA recommends the reservation at the following hotel
Melia Lebreros
C. Luis de Morales, 2
41018 Seville
Spain
Tel: +34 954 57 94 00
PDA Europe has reserved a limited number of rooms by 01 August 2023.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.
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Pricing Options
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Member Price
€ 1.895GovernmentMember Only
€ 1.895
Health AuthorityMember Only
€ 1.895
Early Career ProfessionalMember Only
€ 1.895
StudentMember Only
€ 1.895
AcademicMember Only
€ 1.895
Non-Member
€ 1.895
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
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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.
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