Conference and Respective Track Feedback

Five minute, ten question survey to help us enhance your future ISPE experience.
The responses are anonymous.

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* 1. How would you rate your level of satisfaction with this ISPE 2017 Europe Annual Conference in the following areas?

  Poor Fair Good Very Good Excellent
Technical Content
Opportunity to interact with the speakers
Opportunity to interact/network with other delegates
Quality of the venue
Location accessibility
Overall experience

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* 2. How likely is it that you would recommend the event to a friend or colleague?

Not at all likely
Extremely likely

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* 3. Why did you register for this ISPE 2017 Europe Annual Conference? Please tick all boxes that apply.

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* 4. How did you learn about this ISPE 2017 Europe Annual Conference?

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* 5. Please evaluate the relevance and presentation of the
Keynote speakers

  Poor Fair Good Very Good Excellent
Juan Andres, Global Head Technical Operations (Manufacturing and Supply Chain), Novartis Pharma - Pharma Manufacturing 2025
Gert Mølgaard, Senior Consultant, Mølgaard Consulting - The Hot Spot: Aseptic Manufacturing Trends Towards 2025
Pierre-Alain Ruffieux, Global Head of Quality and Compliance, Roche - Quality 2025
Robert Nass, SVP Quality and Regulatory Management, Merck KGaA - Enabling Future Pharma Manufacturing – Trends From a Supplier Perspective

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* 6. Please evaluate the relevance and presentation of the speakers of
Track 1: Factories Of The Future

  Poor Fair Good Very Good Excellent
Matthew Kennedy, Process Engineer AND Dave DiProspero, Associate, Director of Pharmaceutical Process Technology, CRB Consulting Engineers - Continuous Manufacturing in Biotech and OSD - Including ISPE’s New OSD Guideline
Richard Steiner, Sales Manager, APC Pharma, GEA - Continuous Manufacturing Solutions for Oral Solid Dosage Products - GEA Group
Klaus N Moeller, Head of Business Development, Glatt Air Techniques , Inc. - Technical Solutions for Continuous Manufacturing: Modular Continuous Processing
Marc Michaelis, Pharmacist/Senior Scientist, Hüttlin GmbH, A Bosch Packaging Technology Company - Continuous Manufacturing as an Enabler for Industry 4.0
Stefania Barzanti, Marketing Manager, IMA ACTIVE Division - IMA S.p.A.
Li Jianming, China FDA - 2016 China Drug Inspection Report
Miriam Monge, Director of Marketing and Process Development, Sartorius Stedim AND Nienke Vriezen, Director Upstream, Synthon Biopharmaceuticals - Smart Design and Implementation of Synthon’s New Single-Use Facility
Laurent Arnould, Senior Manager, Global Sourcing and Third-Party Manufacturing, Abbott AND Michel Raschas, Consulting Validation and Services Director, PROGMP SAS - Serialisation at CMOs in Europe : A Case Study for a Proposal of new ISPE CoP
Fatma Taman, General Manager, PharmaVision Pharmaceutical - Mass Serialisation Implementation in Turkey
Gert Vleugels, Global Programme Manager Track-and-Trace, Merck KgA - Serialisation - Opportunities and Challenges of Implementation
Marcel de Grutter, Executive Director, Open-SCS - Global Packaging Serialisation
Lars Olsen, Global Technology Partner - Assembly and Packaging, NNE Pharmaplan - Serialisation: Global Overview and Trends, EU Delegated Acts: Opportunities and Challenges
Kavita Ramalingam Iyer, Regulatory Professional, GRACS- Vaccine CMC, Merck Sharp & Dohme Corp. - An Experimental Approach Supporting QRM Evaluations: Enabling Closed Systems In CNC Environment
Eva Urban, Senior Manager, Global Quality Risk Management, Celgene - Integrating Quality Systems With CMOs Within the Manufacturing Network of the Future
Ranj Rihal, Product Expert for ORION Purified Water AND Nick Barton, Product Expert for POLARIS Distillation, Veolia Water Technologies - How To Manage the Perceived Risks Associated With RO-based Systems for Production of WFI
Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE - International Regulatory Convergence – Is Enough Being Done?

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* 7. Please evaluate the relevance and presentation of the speakers of 
Track 2: Advanced Aseptic Processing

  Poor Fair Good Very Good Excellent
Roland Guinet, Senior GMDP expert, RGmp Compliance - The New Annex 1: What We Already Know and Some Possible Modifications
Monika Stieglbauer, Ph.D.-student, University of Tübingen - Small Batches Manufacturing in Hospital Pharmacies
Patrick Baleriaux, CEO, Aseptic Technologies SA - cGMP Fill-Finish Of Cell - and Gene Therapies With Grade C Background
Elaine Strong, Lead Pharma Solutions, Piramal Healthcare UK Ltd. - Containment in ADC Manufacturing
Lothar Germeroth, SVP, Juno Therapeutics, Inc. - Cell - and Gene Therapy
Michael Dieterle, Director, Boehringer Ingelheim AND Jan Schäfer, Manager Process Engineering, Sartorius Stedim Systems GmbH - Boehringer Ingelheim 2000L Commercial Manufacturing in Single-Use
Markus Keller, Research Engineer and Biologist, Fraunhofer Institute for Manufacturing Engineering and Automation IPA - Cleanroom Suitability Qualification Af a Six-Axis Robot System
Ruben Rizzo, International Sales Manager Projects, SKAN - Isolator Technology VHP Fast Cycles
Jean-Pascal Zambaux, President and CEO, Disposable-Lab - Disposable Isolator For Small ATMP Products
Niels Guldager, Global Technology Partner, Biotech, NNE Pharmaplan - Is The Biotech Facility of The Future Located In China? Learnings From 15 Flexibile Facility Biotech Projects (2012-2017)

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* 8. Please evaluate the relevance and presentation of the speakers of 
Track 3: Clinical and ATMP Supply Chain

  Poor Fair Good Very Good Excellent
Colin Terry, Partner, Deloitte - Trends In Development of Pharmaceutical Pipelines; Challenges For Pharma Companies and The Clinical Supply Chain
Alain Frix, CT Supply Chain Design and Management, Eli Lilly - Faster Selection, Termination Of Drug Candidates In Early Development Phase
Didier Hallard, Senior Consultant R&D, XENDO - Gene Therapy Products In Clinical Trials: The Impact Of Dealing With a Genetically Modified Organism
Andrea Zobel, Global Senior Director Portfolio Management, Parexel - Regulatory, Clinical and Logistics Challenges Of ATMPs In Clinical Research
Heldin Lee-Höhener, Hoffmann-La Roche AG - Breakthrough Therapies - Case Study
Dan Bell, Vice President, Regulatory Compliance and Technical Affairs, MARKEN
Verónica Torres-Barthelemy, Clinical Supply Management, Bayer - A Climate-Based Approach For IMPs Distribution
Ewald Kamp, Head Clinical Distribution and Supply Service, Hoffmann-La Roche AG - Risk-based Shipping – Some Roche Examples
Marc Sotty, Clinical Supply Chain Operations – Distribution Head, Sanofi - Direct-To-Patient: A Sanofi Story
Ruediger Lomb, Global Director Quality & Technical Compliance, World Courier AND Dan Bell, Vice President, Regulatory Compliance and Technical Affairs, MARKEN - Workshop: Striking The Balance - Application of Risk Management for IMP Distribution
Joana Claverol, CTO Paediatric Clinical trials Unit Manager, FSJD - Empowering Young Patients and Families To Contribute To Peadiatric Clinical Research
David Churchward, Expert GMDP Inspector at Medicines and Healthcare Products Regulatory Agency, MHRA - What is Innovation for Authorities?
Shailesh Patel, Global Director Technology Strategy, Customer Integration, Catalent Pharma Solutions - What Technological Solutions Exist To Support The Clinical Supply Chain Tomorrow?
Sharon Kostishion, Global Clinical Supply Regional Lead, Merck & Co., Inc. - Workshop Topic: Patient Centricity - – Where Are We Going and How Are We Getting There?

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* 9. Please evaluate the relevance and presentation of the speakers of
Track 4: Data Integrity and GAMP®

  Poor Fair Good Very Good Excellent
Sion Wyn, Owner, CONFORMITY - Introducing the New GAMP Data Integrity Guide
David Churchward, Expert GMDP Inspector at Medicines and Healthcare Products Regulatory Agency, MHRA - Data Integrity, the Challenges to Meeting Regulatory Requirement
Valeria Frigerio-Regazzoni, Deputy Vice-President Quality Auditing and Compiance, Merck Serono - Quick Wins for Data Integrity Compliance: GAP Assessment and Solving Case Study
Brian Duncan, Vice President, Engagement Operations, Quality Executive Partners Inc. - Investigating Potential Data Integrity Incidents, Methods and Tools
Christian Wölbeling, Senior Director, Werum - MES: The Data Integrity Engine For Production Control Strategy Execution
Chris Clark, Director and Principal Consultant, TenTenTen Consulting - Identifying and Controlling Risks To The Integrity of Records and Data
Paige Kane, Researcher, Dublin Institute of Technology (DIT) - Knowledge Management: A Key To Data Integrity
Mike Rutherford, Consultant, Laboratory & Quality Systems, Eli Lilly - GAMP Data Integrity Guide: Managing Data Throughout The Data Lifecycle
Marina Mangold, Clinical Research Professional, Esculape - Ensuring Data Integrity In Clinical Trials
Anders Vidstrup, Senior IT Quality SME, NNIT - Implementation Of Cloud Solution At Supplier Site and Data Integrity Controls
Ian Thrussell, Expert Inspector, Recently Retired from WHO - WHO Data Integrity Guidance
Nuala Calnan, Regulatory Science Researcher, Author and Consultant, Dublin Institute of Technology - Address Human Factors of Data Integrity
Jean-Marc Jehl, QA CSV, CSQ & IT specialist, Eli Lilly and Company - Managing Data Integrity in a GMP Environment/Data Integrity Within the Manufacturing Area
Mark Newton, Associate Senior Quality Assurance Consultant, Eli Lilly - Detecting Data Integrity Issues with Analytics

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* 10. Please evaluate the relevance and experience of the plant tours

  Poor Fair Good Very Good Excellent
Grifols Plant
Almirall Plant
Biomedical Research Park
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