ISPE 2017 Europe Annual Conference in Barcelona, Spain 3 - 5 April 2017

Education Highlights

Download Schedule Conference Tracks

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.

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Keynote Speakers

Juan Andres Photograph
Juan Andres
Global Head, Technical Operations
(Manufacturing and Supply Chain)
Novartis Pharma.
Gert Moelgaard Photograph
Gert Moelgaard
Senior Consultant
Moelgaard Consulting
Pierre Alain Ruffieux Photograph
Pierre Alain Ruffieux
Global Head of Quality and Compliance
Roche
Christian Wölbeling Photograph
Christian Wölbeling
Senior Director Global Accounts
Werum IT Solutions.

EMA and FDA Regulators Invited
Regulatory challenges in the clinical and commercial supply chain will be addressed from a global perspective, with input from both sides of the Atlantic.

Executive Forum Speakers

Christian Bechon Photograph
Christian Bechon
Chairman and Chief Executive Officer
LFB
Wolfram Carius Photograph
Wolfram Carius
Senior Vice President
Pharmaceutical Operations
Bayer AG
Juan G. Hernandez Photograph
Juan G. Hernandez
President, Life Sciences &
Advanced Manufacturing
Fluor Corporation
Paul Rutten Photograph
Paul Rutten
Partner
Mc Kinsey & Co.
François Sallans Photograph
François Sallans
Vice President, Quality and Compliance and Chief Quality Officer
Johnson & Johnson
Christian Wölbeling Photograph
Christian Wölbeling
Senior Director Global Accounts
Werum IT Solutions.

Conference Tracks

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.

Chairs

Gert Moelgaard Photograph
Gert Moelgaard
Senior Consultant
Moelgaard Consulting
Jean-François Duliere Photograph
Jean-François Duliere
Senior Pharmaceutical Expert
Technip

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.

Chairs

Charlotte Enghave Fruergaard Photograph
Charlotte Enghave Fruergaard
Partner
Process Technology Consulting
Past Chairman ISPE Intl. Board
NNE Pharmaplan
Philippe Robin Photograph
Philippe Robin
Consultant Senior Pharmacie
JACOBS

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.

Chairs

Saskia Wichmann Photograph
Saskia Wichmann
Head of Clinical Supply Management PO
Bayer
Bernd Steffens Photograph
Bernd Steffens
Head Global CTSU
Boehringer Ingelheim

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.

Chairs

Chris Reid Photograph
Chris Reid
Managing Director
Integrity Solutions Ltd.
Heather Watson Photograph
Heather Watson
Director, Computer Systems QA
GSK

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.


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