Executive Forum and Keynotes
Factors Influencing Management Perspective
Operational excellence will remain the key solution to keep the license of business at an affordable cost level. Join us to hear experts talk about how they approach these hot topics:
- New concepts for continuous manufacturing in small molecules API synthesis and in large molecule biologics manufacturing will disclose new ways to shorten manufacturing processes.
- Rapidly changing product portfolios will drive new modular facility design concepts.
- Key success factors for more flexible and agile operations are effective and efficient change management systems, supported by validated computerised systems and applications as a platform.
- Overarching production control strategy is described as “industry 4.0” and is far more than automation of processes and direct interaction of machines and equipment. An adaptive risk-based monitoring is one of the key elements in such a control strategy.
- Regulatory environment for all these operations continues to be complex and not harmonised on a global level, which results in quality manufacturing and regulatory issues e.g. the supply in developing countries and emerging markets.
Above all, the number one focus is to deliver equally safe, effective, and high quality medical drugs to the patient in every part of the world. Explore the conference tracks below to plan your personalised ISPE 2017 Europe Annual Conference experience.
Track 1: Factories of the Future
Pharmaceutical factories of the future can be significantly different from the mainstream solutions of today. Representatives from several pharma companies that have planned and implemented innovative approaches will share their experiences and best practices.
Learn how to improve your manufacturing capability and productivity within manufacturing through inspiring presentations on continuous manufacturing, serialisation, and business excellence from some of the biggest equipment suppliers to pharmaceutical manufacturing. Practical project case studies and operational experiences focusing on pharmaceutical facilities of the future complete the track, building on the tradition of successful events over the last three years.
Track 2: Advanced Aseptic Processing
Through case studies, presentations, and discussion groups, industry and international regulators will cover the topics that impact you, including Annex 1, Small Batch Production, Single-Use, Robot Systems, Containment, and Isolator Technology. Attendees will have the chance to interact with regulators and speakers throughout the conference.
Track 3: Clinical and ATMP Supply Chain
Take advantage of this opportunity to meet with Clinical and ATMP Supply Chain professionals, touching on accelerated drug development and GDP & GMP Annex 15 risk management in an interactive forum. You will gain new insights into industry efforts on patient centricity and innovative supply chain approaches that foster quicker drug development and keep patients engaged in clinical trials.
Find the right answers to support the accelerated development efforts.
- How can we accelerate the activities along the clinical trial supply chain?
- How do GDP and GMP regulations support such trends as needed?
- How to make progress on patient centricity and what are the new innovations?
The Clinical and ATMP Supply Chain Track is designed to help peers connect and exchange industry knowledge. Expert speakers will share new approaches and their best practices, while attendees will gain the opportunity to interact with colleagues in workshops utilizing case studies and innovative presentations.
Track 4: Data Integrity and GAMP®
Global regulatory authorities‘ concerns are growing regarding the reliability of records and data against which product quality and patient safety decisions are made. This is demonstrated through Data Integrity guidance publications from the UK MHRA, World Health Organisation (WHO), and US FDA, coupled with numerous regulator citation highlights.
The Data Integrity-GAMP® track will examine the multi-faceted risks to data integrity, including corporate pressures and incentives, human behaviours, and inadequate process and system controls.
We are excited to have assembled world-class sessions counting global speakers from regulatory authorities, industry, service providers, academia, and users of critical records and data. The track will examine all aspects of data integrity incorporating the human factor, business processes, and technical controls. This track will also address data integrity challenges throughout the product lifecycle with sessions relating to clinical, manufacturing, and laboratories. The exchange between the speakers and attendees promises to be interactive, innovative, and educational.