pda.org/EU/PM2019

REGISTER BEFORE 7 JULY AND SAVE UP TO €200!

5 SEPTEMBER 2019 MUNICH, GERMANY

IG MEETING: 2 SEPTEMBEREXHIBITION: 5 SEPTEMBERTRAINING: 3-4 SEPTEMBER

2019 PDA EUROPE

Project Management in the Pharmaceutical Industry

Peter Reichert, Zelect Quality – ZQI, Chair

Scientific Program Planning Committee

Peter Reichert, Chair, Zelect Quality – ZQI

Resu Alloza, ReAl CMC Consultancy

Stefan Schuh, Bosch

Thomas Bo Sølver, Eltronic

Garrett van Vactor, Novartis

Michael Walliser, Camelot Management Consultants

Kerstin Wilken, PDA Europe

Teresa Schubach, PDA Europe; Manager Programs & Events

LETTER FROM THE CHAIR

Dear Colleagues,

PDA Europe is proud to announce the second edition of the PDA Europe Conference on Project Management in the Pharmaceutical Industry to be held in Munich, Germany on 5 September 2019.

The pharmaceutical industry has regulations and best-practice manuals for most of its production pro-cesses. Nonetheless, Project Management as a discipline is often excluded from the standards of per-formance defined for many other fields in the industry. It is apparent, the industry needs trained Project Managers in order to achieve success in the numerous processes, projects and developments.

PDA has recognized the need and offers this discipline its own space. One of the initiatives has been the novel conference on Project Management in the Pharmaceutical Industry in 2018.

If you are Project Manager working in the pharmaceutical industry you cannot miss this event. The conference has been designed by certified Project Managers with many years of experience in the pharmaceutical industry. We will discuss topics such as the advan-tages and challenges of different Project Management methods, tech transfer, risk management and best practices. In an interactive session, participants will develop approaches to challenges present-ed by experienced SME by the means of real-life case studies in small working groups.

A session will be dedicated to Young Professionals presenting hot topics within our industry in short, concise presentations.

This event will offer excellent opportunities to expand your profes-sional network with other experts in similar positions– Join us and deepen your knowledge of Project Management in our industry.

I look forward to meeting you in beautiful Munich!

Sincerely,

Peter Reichert

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HEADER HEADLINE

S C H E D U L E A T A G L A N C E

2 September 10:00 – 17:00 Technology Transfer Interest Group Meeting

3 September4 September

9:00 – 18:009:00 – 16:00

Managing Technology Transfer Projects in Pharma

Training Course

5 September 9:00 – 17:30 Project Management in thePharmaceutical Industry

Conference, Exhibition

For latest information, please visit: pda.org/EU/PM2019

WELCOME TOMUNICH

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Technology Transfer PDA Europe is proud to announce the first IG Meeting Technology Transfer in Europe!

Dear Colleagues,

Technology transfers play an increasingly vital role due to a rise in outsourced operations and corporate acquisitions. To ensure drug supply the pharmaceutical industry is registering a tremendous increase of Technology Transfer activities. This entails technical and business-related challenges for big pharma as well as for small or virtual companies. Concise expertise and a robust approach are needed to drive for success. Therefore, PDA created the Technology Transfer Interest Group in 2016 with a clear goal: subject matter experts need to be connected and discuss about best practices, challenges and anticipation of needs and trends.

This vision in mind, we are proud to announce the first F2F IG Meeting Technology Transfer in Europe as a prelude to the inaugural 2019 PDA Europe conference on Biomanufacturing and the second edition of the conference on Project Management in the Pharmaceutical Industry to take place in Munich Germany, on 3-4 September and 5 September, respectively

This meeting will focus on discussions around:

• Recent activities of the Interest Group and achievements made in past 2 years

• The 2019 survey on how companies handle the challenges of technology transfers, including their knowledge and risk management, documentation, and business strategies

• Regulatory implications and the impact of emerging technologies

• Technology Transfer Matrix developed as a tool to cross-link teams and main activities needed during a Technology Transfer and to enable benchmarking in the industry.

• Future action plan for the Interest Group and current hot topics in Technology Transfer

Take advantage of the open forum design and hear presentations from leading experts, interact and discuss your experiences with colleagues in round table discussions. Interested in sharing your knowledge and experience with your colleagues? We welcome submission of presentations focused specifically on the meeting topic or other relevant topics of current interest to the industry.

Please send your proposal no later than 9 August 2019, to the attention of Teresa Schubach: schubach@pda.org

Mirko Gabriele, Production Director, Thermo Fischer Scientific

Mirko joined Patheon, now part of Thermo Fisher Scientific, in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager, Manager of Technology Transfer Respon-sibility and Global TT Sr. Manager for commercial unit for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies. Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since 2014. Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July 2014.

INTEREST GROUP MEETING

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INTEREST GROUP MEETING AGENDA

28 June 2019

Monday, 2 September 2019 10:00 – 17:00

10:00 Welcome and Introduction · Short Introduction and Benefits of the PDA Interest Group · PDA Connect

Kerstin Wilken, PDA Europe

Mirko Gabriele, Thermo Fisher Scientific

10:15 Recent Activities of the Interest Group Technology Transfer and Achievements over the Past 2 Years

Mirko Gabriele, Thermo Fisher Scientific

11:00 Q&A, Discussion

11:30 Coffee Break, Poster Session & Exhibition

Results of the 2019 Technology Transfer Survey & the Use of the Technology Transfer Matrix as a Tool

12:00 The 2019 Survey on the Challenges of Technology Transfer Beth Haas, Commissioning Agents

12:30 How to Use a Technology Transfer Matrix as a Tool Beth Haas, Commissioning Agents

13:00 Q&A, Discussion

13:30 Lunch Break, Poster Session & Exhibition

Roundtable Discussions

14:30 Short introduction to hot topics to be discussed

14:45 Preparation of Roundtable Discussion: · Roles and responsibilities in technolgy transfer execution · The use of communication as a tool to ensure success

15:30 Coffee Break & Exhibition

16:00 Roundtable Discussion

16:45 Summary of the IG Meeting and future actions of the Interest Group Mirko Gabriele, Thermo Fisher Scientific

17:00 End of IG Meeting and Farewell Mirko Gabriele, Thermo Fisher Scientific

Kerstin Wilken, PDA Europe

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TWO-DAY TRAINING COURSE

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

Managing Technology Transfer Projects in PharmaIn 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 pharma-ceutical industry!

The PDA Europe Managing of Tech Transfer Projects in Pharma course will help you to understand the opportunities proj-ect 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 coming from different areas such as

- Qualification/Validation Engineers - Qualified Persons - Responsible Persons - Security Specialists - Regulatory Affairs Specialists

Mirko Gabriele, Production Director, Thermo Fischer Scientific

Mirko joined Patheon, now part of Thermo Fisher Scientific, in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager, Manager of Technology Transfer Respon-sibility and Global TT Sr. Manager for commercial unit for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies. Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since 2014. Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July 2014.

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TRAINING COURSE AGENDA

Tuesday, 3 September 2019 9:00 – 18:00

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 a

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 RiskManagement• Risk Management in pharma principles• Risk Management Tools

16:45 Change Management• Project Change• Change Management Process• Change Management Plan

17:15 Q&A

18:00 End of Day 1

Wednesday, 4 September 2019 9:00 – 16:00

9:00 Case Study 1 (Technology Transfer from Development to Commercial) • Project Chart Creation• Stakeholder Map Ddefinition• Costs and Business Case Evaluation• Technology Transfer Timelines Principles and

Gantt Definition

10:30 Coffee Break

9:00 Case Study 1 (Technology Transfer from Development to Commercial) (Continued)

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

28 June 2019

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CONFERENCE AGENDA

28 June 2019

Thursday, 5 September 20199:00 Welcome and Introduction Kerstin Wilken, PDA Europe

Peter Reichert, Zelect Quality

9:15 Keynote: Failed Projects and What to Learn from Them Oliver Lehmann, PMI Southern Germany Chapter

Session 1: Lifecycle and Interface Management in Pharma Moderator: Garrett van Vactor, Novartis

10:00 Lifecycle Management – Uncertainties and Opportunities Peter Reichert, Zelect Quality Thomas Bo Sølver, Eltronic Resu Alloza, ReAl CMC Consultancy

Q&A, Discussion

11:30 Coffee Break, Poster Session & Exhibition

Session 2: Traditional, Agile, Adaptive - Conflict or Complementation?

Moderator: Stefan Schuh, Bosch

12:00 Adaptive Project Management: What We Learned from the Agile Methodology for Long Term Pharma Projects

Biotest AG, invited

Q&A, Discussion

13:10 Lunch Break, Poster Session & Exhibition

Interactive Session: Working Tables Moderator: Resu Alloza, ReAl CMC Consultancy

14:10 Resource Management

Pharmaceutical Tech Transfer

Optimizing Portfolio Management

Making Collaborations Work

Moderator: Holger Eckert,

Proventis

Moderator: Mirko Gabriele,

Thermo Fisher Scientific

Moderator: Lucy Peltenburg,

Ganttenburg Consultancy

Moderator: Peter Reichert, Zelect Quality

Summary of Round Table Discussions

15:30 Coffee Break, Poster Session & Exhibition

Session 3: Young Professionals in Project Management Moderator: Michael Walliser, Camelot Management Consultants

16:00 Young Professionals will Present Hot Topics in Short and Concise Presentations• Data Integrity• Approaches to different Methodologies• Risk Management

How Companies Succeed in the Face of Differently Paced Project Management

Camelot Management Consultants, invited

Understanding Governance and Key Relationships in Digital Projects Novartis, invited

Q&A, Discussion

Closing Plenary

Interactive Summary Kerstin Wilken, PDA Europe Peter Reichert, Zelect Quality

17:30 Closing of the Conference and Farewell Kerstin Wilken, PDA Europe Peter Reichert, Zelect Quality

Program subject to changes without notice

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PDA Scientific Poster PresentationExhibit Your Work

Canvas size to work on:85 cm x 120 cm (33,465 x 47,244 in) – portrait formatSlug / Bleed: 2 mm (0,079 in)

Images: 120dpi (low) - 150dpi (high) depending on size.All Images Color Profile ISO Coated v2 (ECI)

Document size of the PDF:85 cm x 206 cm (33,465 x 81,102 in) – portrait formatSlug / Bleed: 2 mm (0,079 in)

All posters will be printed by PDA and displayed as part of the exhibition. Poster display is included in the regular conference registration fee. Please send your file and poster title to wilken@pda.org.

Deadline:

19 July 2019

To join our scientific poster session, the poster has to be non-commercial in nature. Please send a printable PDF file according to the following specifications:

9pda.org/EU/PM2019

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully sett-led. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 14 July 2019 you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to re-ceive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at registration-europe@pda.org or fax to + 49 30 436 55 08-66.

VENUESheraton Munich Arabellapark HotelArabellastraße 5 81925 Munich, Germany tel:+49 (0)89)92320 https://goo.gl/sb1Rn9

Special RatesPDA Europe has reserved a limited number of bedrooms until the 7 July 2019. Book your group rate for PDA.Single Room 169 € per room and night Double Room 194 € per room and 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 Charge will apply. Housing at the selected hotel will be in high demand, so we strongly recommend making your reservations early.

CONTACT INFORMATIONConference/Exhibition/Sponsorship InquiriesMelanie DeckerDirector Events & Exhibitionsdecker@pda.orgConference Program InquiriesTeresa Schubachprograms-europe@pda.orgRegistration Customer CareTel: + 49 30 436 55 08-10registration-europe@pda.orgEducation Program InquiriesElke von Laufenbergtraining-europe@pda.org

GENERAL ADDRESSPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: + 49 30 436 55 08-0Fax: + 49 30 436 55 08-66

CONFERENCE REGISTRATION HOURSThursday, 5 September: 8:00 – 15:00

IG MEETING / COURSE REGISTRATION HOURSMonday, 2 September: 8:00 – 12:00Tuesday, 3 September: 8:00 – 17:00Wednesday, 4 September: 8:00 – 12:00

TO EXHIBIT:Exhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly- qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.

SPECIAL REQUIREMENTSIf you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific

questions can be directed to registration-europe@pda.org.

DIRECTIONS

Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to participants, visitors, exhibitors, in-vited guests as well as employees of the Contracting partner and their travel companions. To make a reservation, please click on www.lh.com/event-flight-booking and enter the access code DEZQWLQ in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to lufthansa.mobility@dlh.de and providing the access code as a reference.

INFORMATION

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3 WAYS TO REGISTER

online: pda.org/EU/PM2019FAX: + 49 30 436 55 08-66Email: registration-europe@pda.org

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Book by 7 July 2019 to receive the reduced conference fee onlyEARLY BIRD DISCOUNT

Conference (5 September 2019) netPDA Member Early Bird 895 995Nonmember Early Bird 1195 1395Govern./Health Authority/Academic/ 1Young Professionals EB 400 500

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CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully sett-led. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 excl. VAT per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 14 July 2019 you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to re-ceive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at registration-europe@pda.org or fax to + 49 30 436 55 08-66.

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IG Meeting (2 September)Technology Transfer All Participants 350

Two-Day Training Course (3-4 September)Managing Technology Transfer Projects in PharmaAll Participants 1595

For contact at PDA Europeregistration-europe@pda.org2-5 September 2019 | Munich | Germany

Project Management in the Pharmaceutical Industry

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.

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2 0 19

2 September2 September3-4 September5 September

Interest Group Meeting Freeze DryingInterest Group Meeting Technology TransferBioManufacturingInterest Group Meeting Vaccines

Munich, Germany

2 September5 September

Interest Group Meeting Technology Transfer Project Management in the Pharmaceutical Industry Munich, Germany

24-25 September Pharmaceutical Freeze Drying Technology Berlin, Germany

24-25 September Particles in Injectables Berlin, Germany

21 October21 October21 October22-23 October

Workshops:Innovating the Journey from Manufacturing to the PatientInnovative Drug Delivery Systems/Combination ProductsImpact of Pre-fi lled Syringe Components on BiopharmaceuticalsThe Universe of Pre-fi lled Syringes and Injection Devices

Gothenburg, Sweden

12-13 November14 November

Pharma Logistics & Outsourced OperationsInterest Group Meeting Supply Chain Management Lisbon, Portugal

2 0 2 0

25-26 February Parenteral Packaging Basel, Switzerland

21-22 April Visual Inspection Forum Berlin, Germany

Subject to change For latest info: europe.pda.org Shortlist 28 Jun 2019

CONNECTINGPEOPLE SCIENCE AND

REGULATION®

europe.pda.org

GENERAL INFORMATIONPDA EUROPE GGMBHAM BORSIGTURM 60

13507 BERLIN, GERMANYTEL: +49 30 4365508-0

FAX: +49 30 4365508-66INFO-EUROPE@PDA.ORG

P DA E U R O P E E V E N T S