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 manufacturing needs to move and change towards more agile and flexible manufacturing in order to meet the new regulatory expectations. The Factory of the Future track is covering the regulatory expectations and opportunities for new manufacturing technologies such as continuous manufacturing. The track covers a range of hot topics regarding existing and new pharmaceutical facilities and their operations.
You will get inspiration on how to improve manufacturing productivity and learn about new technologies from some of the biggest equipment suppliers to pharmaceutical manufacturing. Practical project case studies and operational experiences focusing on pharmaceutical facilities of the future will complete the track, building on the tradition of successful events over the last three years.
Track 2: Advanced Aseptic Processing
The Sterile and Aseptic Manufacturing track will present a range of hot topics regarding manufacturing of sterile/aseptic products. This includes an update on Annex 1, small batches manufacturing, cell and gene therapy as well as trends in advanced Aseptic processing. The presentations will cover regulatory requirements, technical improvements, and case studies.
Furthermore, the conference will provide unique opportunities to network with peers in the industry.
Track 3: Clinical and ATMP Supply Chain
Our industry has the continuous need to evolve. New challenges are on the horizon, such as acceleration of drug development utilising research methods, bridging and dosing studies, orphan drug developments, and breakthrough therapies. At the same time, it is very critical to recruit patients in time and even more important to keep them engaged. Clinical Trial Supplies experts need to 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 Investigational Products Track is designed to peers to 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 and how this information is being utilized in product quality and patient safety decisions. 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.
This track will examine the multi-faceted risks to data integrity, including corporate pressures and incentives, human behaviours, and inadequate processes 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.