10:00 Reducing Complexity in Pharma Marc Philipp & Markus Hayek, Accenture. Session 1 Regulatory Updates Moderator: Jette Christensen, Novo Nordisk

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1 Tuesday, 26 June Jun :00 Welcome & Opening Remarks Introduction & PDA Appreciation Awards Falk Klar, PDA Europe Jette Christensen, Chair, Novo Nordisk Borke Van Belle, Chair, Janssen J&J Keynotes: Pharmaceutical Industry Highlights - Past, Present, Future Moderator: Borke Van Belle, Chair, Janssen J&J The Pharmaceutical Industry is evolving quickly. The model is quickly shifting from generating blockbusters for disease treatment to targeted solutions that improve individual outcomes, prevention, chronic diseases, and identify new opportunities. The landscape in which we operate also needs to take into consideration the changing expectations of patients, healthcare professionals, payers and regulators. This session zooms in and highlights some of these aspects. 9:30 Future Opportunities and Directions for Pharmaceutical Manufacturing A Global View Axel Glatz, Pfizer 10:00 Reducing Complexity in Pharma Marc Philipp & Markus Hayek, Accenture 10:30 The Patient s Perspective: Past, Present & Future of Diagnosis and Therapy Jette Christensen, Patient 11:00 Coffee Break, Poster Session & Exhibition Session 1 Regulatory Updates Moderator: Jette Christensen, Novo Nordisk In this session, you will hear regulatory and industry perspectives on current regulatory hot topics. 11:30 Regulatory Update Roberto Conocchia, European Medicines Agency 12:00 PDA Task Force Annex 1 Revision: Industry Comments Hal Baseman, ValSource 12:30 Activity Update on PUPSIT Maik Jornitz, G-CON Manufacturing 13:00 Q&A, Discussion 13:30 Lunch Break, Poster Session & Exhibition TRANSITION TO PARALLEL TRACKS 12 pda.org/eu/annual2018

2 Session 2 TRACK A TRACK B Big Data Moderator: Ulrike Malordy, PQE Industry 4.0 is changing the industrial landscape in general and the pharmaceutical industry is no exception. Based on compliant processes for Data Integrity, pharma companies now have the opportunity to improve processes with the help of real time process data and thereby reach data based decisions. This promises an improvement in the quality of processes and push process efficiency. 14:30 Big Data Integrity: How to Succeed in the Challenge Using the Cloud Toni Manzano, Bigfinite 14:55 Managing the Digital Transformation Sebastian Schmitz, Industry 4.0 Maturity Center 15:20 What s in Your Data? PDA Tackles Insights at the Shop Floor Aaron Goerke, Roche Managing Manufacturing Moderator: Borke Van Belle, Janssen J&J Pharmaceutical manufacturing is undergoing significant changes: batch sizes decrease, flexibility increases, personalized medicines and serialization have entered the manufacturing units, and digitalization is making leap progress. This session helps provide insight in these ever-increasing demands, and in the opportunities they bring. Enabling Agile Digitalization towards Industry / Pharma 4.0 Rene Zoelfl, Parametric Technology GmbH (PTC) Process, Product, Patient Advanced Process Control in Manufacturing Olav Lyngberg, Janssen J&J A Continuous Improvement Metric for Bio-Pharmaceutical Manufacturing Ajay Babu Pazhayattil, Eurofins Alphora 15:45 Coffee Break, Poster Session & Exhibition PARALLEL TRACKS Session 3 TRACK A TRACK B New Era of Manufacturing Technology Moderator: Yves Mayeresse, GSK Engineering should evolve at the same pace as other part of the pharmaceutical industry. Technology improvement is there to create value for the companies. Today few trends appear to predict future factory. One of them it s to go from big to small size in order to address more specific need, this point will be highlighted through a case study on factory of the future. Another trend is human versus robot use. In one presentation, the automation of human task will be presented with software Robotic Process Automation. In a second part, a rigorous technology management approach from Ideation, Feasibility Testing, Pilot and Full implementation that requires culture and strong processes will be explained. Digital Health & Precision Medicine Patient Centricity Moderator: Chris Procyshyn, VanRX The combination of today s advances in microprocessing power and genomic data are enabling completely new models for diagnosing and managing the delivery of therapeutic needs. While our digital lives are constantly adding and adapting to new technologies, the applications of these similar techniques and capabilities offers new challenges and opportunities for drug delivery. This session will focus on examples of these applications, along with the challenges and considerations necessary to make the potential advances become reality.

16:15 Targeted Innovation Management & Examples in Fill & Finish Timo Simmen, Janssen J&J 16:45 Robotic Process Automation (RPA) Frederik Strecker Kruse, Novo Nordisk 17:15 Factories of the Future to

3 16:15 Targeted Innovation Management & Examples in Fill & Finish Timo Simmen, Janssen J&J 16:45 Robotic Process Automation (RPA) Frederik Strecker Kruse, Novo Nordisk 17:15 Factories of the Future to Factories of the Here and Now New Generation Biologics Indu Conley, DPS Global Introducing a New Age of User-Centricity - Applying Eye-tracking to the Development of New Combination Products Andreas Schneider, Ypsomed Why Better Human Understanding is the Only Future Craig Scott, Greensand Empowering Chronotherapy through Connected Devices and Digital Technologies Agnes Fritsch, Altran 17:45 Q&A, Discussion Q&A, Discussion 18:00 End of Day 1 & Networking Event 14 pda.org/eu/annual2018

4 Wednesday, 27 June 2018 PARALLEL TRACKS Session 4 TRACK A TRACK B Smart Industry Moderator: Toni Manzano, Bigfinite The 4 th Industrial Revolution was publicly announced in 2011 at the Hannover Fair1. Since then, elements such as the Digital Twins, Industrial Internet of Things or Cyber Physical Systems have come into the scene as unseparated elements, providing the necessary ingredients for a paradigm shift in many manufacturing areas. Over all these components, the most pioneering are related with the predictive analytics and artificial intelligence, directly applied to real use cases without resolution just a few years ago. How is the Pharma industry adopting this challenge? 9:00 The Smart Industry, A Reality Affordable with Courage Kasper Malte Larsen, Novo Nordisk 9:30 The Digital Robot Pharma Factory Martin Dueblin, One One Eleven 10:00 Smart Packaging as an Enabler for an Outcome Based Healthcare System Uwe Braun, Schreiner MediPharm Regulatory Perspectives Moderator: Barbara Allen, Eli Lilly The regulatory environment continues to evolve. Participants will receive updates on key hot topics, hear about PDA initiatives and have the opportunity to seek and share challenges and ideas. ICH Q12 and Post Approval Change: PDA Innovation for Availability of Medicines (PAC iam) Ursula Busse, Novartis & Emma Ramnarine, Genentech Knowledge as an Asset: Accelerating Knowledge Availability Across the Lifecycle Paige Kane, Dublin Institute of Technology / MSD Assessing and Improving Quality Culture: Tools and Resources Susan Schniepp, Regulatory Compliance Associates 10:30 Q&A, Discussion Q&A, Discussion 10:45 Coffee Break, Poster Session & Exhibition pda.org/eu/annual

5 PARALLEL TRACKS Session 5 TRACK A TRACK B Young Professionals in PDA Moderator: Jette Christensen, Novo Nordisk PDA is focusing on diversity and we are welcoming young professionals to present. This session does not require a special topic to be presented; instead young professionals will share with us what they are working with and which are of interest for most of us. 11:15-11:30 Protein Powder Suspensions in Non-Aqueous Vehicles A Potential Alternative to Conventional Formulations? Christoph Marschall, Ludwig-Maximilians-University 11:30-11:45 Establishing Communities of Practice for Effective Knowledge Management in the Pharmaceutical Industry Rita Ruth Hampe, Novartis 11:45-12:00 Continued Process Verification: A Maturity Model for Industry Gavin Kinsella, Amgen 12:00-12:15 Holistic Approach to System and User Dependencies Data Integrity Moderator: Aidan Harrington, DPS Group The Data Integrity presentations dealing with audit trail review, the human element and governance across corporate networks represent three of the most relevant DI topics that impact the industry today. While these DI topics are well-known, the challenge for the industry is to be aligned in its response. Each presentation presents solutions and proposals to ensure that data can be trusted. These will help align attendees and the industry in its responses to the specific scenarios identified. 11:15-11:45 Data Integrity: Eliminating Risk & Human Error in Our Manufacturing and Laboratory Processes Matthew Paquette, Charles River 11:45-12:15 Data Integrity Governance & Metrics to Mitigate Regulatory Risks Across Corporate Networks Danilo Neri, PQE 12:15-12:45 Industry Coalition Position Paper concerning Audit Trail Review Christian Scheidl, Novartis 12:45-13:00 Q&A, Discussion Sofie Rytter, Novo Nordisk 12:15-13:00 Q&A, Discussion 13:00 Lunch Break, Poster Session & Exhibition 16 pda.org/eu/annual2018

6 Closing Plenary Moderator: Yves Mayeresse, GSK Vaccines 14:00 Advanced Manufacturing Technology Andrew Rutter, GSK 14:30 Future Challenges and Opportunities for Manufacturing Site Operations Cristiano Demolli, Eli Lilly 15:00 Coffee Break, Poster Session & Exhibition 15:30 Healthcare of the Future: Multi Organ Chip Technologies Reyk Horland, TissUse 16:00 Panel Discussion, Q & A 16:30 Summary, Conclusions Closing Remarks End of Conference & Farewell Jette Christensen, Novo Nordisk Borke Van Belle, Janssen J&J Falk Klar, PDA Europe The Parenteral Drug Association presents: Pharmaceutical Microbiology Simulcast Conference Register by 26 August 2018 and SAVE! October 2018 Marriott Hotel Berlin Germany

3 rd PDA Europe Annual Meeting

PDA Europe Conference, Exhibition, Education The Parenteral Drug Association presents: 3 rd PDA Europe Annual Meeting Global Healthcare of the Present & the Future Register by 29 April 2018 and SAVE! pda.org/eu/annual2018