2nd PDA Europe Annual Meeting

9:00
Welcome: Opening Remarks

Falk Klar, PDA Europe
Stephan Roenninger, Amgen, Co-Chair
Veronique Davoust,Pfizer, Co-Chair

9:45
International Regulations of Pharmaceuticals in the Future
WHO

10:15
GMP Harmonisation - Challenges and Opportunities
MHRA / PIC/S

10:45
Medical Products & Regulatory System in Iran
IFDA

11:15
Coffee Break, Poster Session & Exhibition

11:45
Challenges in Vaccines Development and Manufacturing
Takeda

12:15
Q&A, Discussion

12:45
Lunch Break, Poster Session & Exhibition

Engineering has always been an applied science, improving technology to deliver cost effective and optimal solutions. New factories and old are built and retrofitted to become more flexible in all of the operations involved. Different tools are available and can be activated to achieve this goal: new operational models, single-use systems, continuous processing and modular approaches. A comparison of different cleanroom designs with the associated benefits and drawbacks will be presented in this session. The world becomes increasingly digital, and also in manufacturing, all the processes along the life-cycle need to become more interconnected. Digital simulation and modelling of any future project helps evaluate the potential for improvement. Feasibility studies, through commissioning, plant management and even maintenance and service need to be made interdependent. Integration allows not only an increase in efficiency, but also a reduction in cost and improvement in overall process and product quality. All these topics will be discussed in detail during this session.

13:45
Comparison of Cleanroom Designs & Structures – Cost and Benefit Review
G-CON Manufacturing

14:15
Flexibility by Design – Flexibility and Innovation in Facility Design for Manufacturing of Tomorrow’s Vital Biopharmaceutical Products
NNE

14:45
From Integrated Engineering to Integrated Operation
Siemens

15:15
Q&A, Discussion

15:45
Coffee Break, Poster Session & Exhibition

The human factor in relation to pharmaceutical products deserves an end-to-end focus. Providing solutions for patients and healthcare workers requires full understanding of the user-to-product interface, the patient's condition and application conditions. This information and insight needs to be built into the product during Research and Development. On the other hand, Good Manufacturing Practices and regulatory expectations applying to supply and distribution chains safeguard the companies and patients through a number of preventive requirements and corrective controls to manage potential impact of the human factor. In this session, we will focus on this end-to-end view, and learn how the patient as ultimate customer is centric in understanding the human factor as being key for the success of a pharmaceutical product.

13:45
User Centered Design: Exploring Physical Capabilities of Intended Users
Novartis

14:15
The Patient Perspective
Cambridge Design Partnership

14:45
How Mixed Reality will Drive the Future of Drug Delivery Product Development
Worrell

15:15
Q&A, Discussion

15:45
Coffee Break, Poster Session & Exhibition

Quality requirements in the supply chain are increasing in an effort to prevent counterfeits and drug shortages. This session will focus on and provide an insight on how risk of drug shortages can be addressed and what manufacturers can do. A tool for managing single and multi-source challenges for drug availability will provide a practical example on how manufacturers and/or Marketing Authorization holders but also wholesalers can manage continued supply. Finally, we will receive an overview on current expectations on the distribution of medicines, highlighting pitfalls from an inspector's point of view.

16:15
Reducing Risk of Drug Products Shortages
GSK

16:45
Managing Single- and Multi-Source Supply Chain Challenges: A Practical Tool
Genentech / Roche

17:15
Experience with GDP Inspections
MHRA

17:45
Q&A, Discussion

18:15
End of Day 1 & Networking Event

Is there any contradiction between quality and cost? Or is it simply the way that lack of quality will immediately increase the cost? This potential dilemma will be scrutinized in conjunction with the importance of Quality Culture both from an industry perspective as well as the view of regulators. Attendees will gain an understanding of the importance to facilitate quality in combination with cost awareness as well as the paramount need for a clear Quality Culture.

16:15
Total Cost of Quality: Speaking Business Language
Janssen J&J

16:45
Developing a Culture of Quality
AstraZeneca

17:15
Are Quality Costs Fully Calculable? A GMP-Inspector's View
District Government of Upper Bavaria

17:45
Q&A, Discussion

18:15
End of Day 1 & Networking Event

With the increased focus on advanced processes, the limits of traditional environmental monitoring methods are being stretched. Experts from a range of companies will provide insight into their experiences with new monitoring technologies, as well as the practical implementation of these technologies into new automated, closed aseptic processes. Attendees will gain an understanding of the regulatory implications and a view to the future.

9:00
Continuous Microbiological Monitoring for Aseptic Manufacturing
Pfizer

9:30
New Advanced Aseptic Filling Technology in a New Greenfield Manufacturing Facility
DPS Engineering

10:00
Repeatable H₂O₂ Measurement during Bio-Decontamination: Measurement Technology, Relative Humidity vs. Relative Saturation and Material Selections
Vaisala

10:30
Q&A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

Do we know the real implication of the digital transformation in the industry? Industrial Internet of Things or Machine to Machine are terms that begin to sound familiar in pharma and that are a reality in the health, automotive and energy sectors. When the cloud concept is added to these ingredients, new concerns arise. The industrial digitalization obviously requires innovative technology, but also a new mindset able to advance people into a new generation driven by connectivity: the era where existing knowledge becomes part of production.

9:00
Driving Digital Transformation: Best Practices for Realizing Value from New Technology within your Organization
Sight Machine

9:30
NDigital Transformation Systems in Healthcare
Altran

10:00
Internet of Things for Predictive Analytics
Ghent University

10:30
Q&A, Discussion

11:00
Coffee Break, Poster Session & Exhibition

11:30
Modular and Scalable Facility Design to Meet Manufacturing Requirements for Modern Therapeutic Approaches
Charité Berlin

12:00
Process Design – Migration to a Modelling Based Workflow
DPS Engineering

12:30
Risk-based Tools for Designating Appropriate Room Classification for Biopharmaceutical Operations in Conceptual Design
Novo Nordisk

13:00
Lunch Break, Poster Session & Exhibition

11:30
Big Data, Internet of Things, Machine Learning, Artificial Intelligence: How to Transform Pharma Manufacturing & Biotech Processes
Bigfinite

12:00
From Bits to Bedside: Developing a Learning Digital Health System to Evaluate Pigmented Skin Lesions
University of California, San Francisco

12:30
Discovering Novel Biomarkers by Robotic Molecular Diagnosis
DRIVER

13:00
Lunch Break, Poster Session & Exhibition

14:00
Light and Life: How Spectroscopy Supports the Life Sciences
Leibniz Institute of Photonic Technology

14:30
Reimbursement and Cost of Quality
BeyondSpring Pharma

15:00
Panel Discussion
Committee Members and Speakers

Quo Vadis, Pharma Industry?

• Disease Management
• Insurance, Coverage
• Mobile Solutions from Diagnosis to Treatment
• Paradigm Shifts: Interconnect R&D, Industry, Patient
• Globalized Medicine: Drug Affordability, Availability

16:00
Summary, Conclusions Closing Remarks End of Conference & Farewell
Falk Klar, PDA Europe