26 April – Room A

09:15 - 09:30 Regulatory Snakes & Ladders – Navigating the Pitfalls of Pharmaceutical Development
Matthew Burton, Senior Project Manager and Auditor - JensonR+ Ltd

09:35 - 09:55 European Falsified Medicines Directive – Securing the Supply Chain
Paul Thomas, Regional Business Development Manager UK & Ireland - Aegate

09:55 - 10:15 New Product – Compliance Future Proofing
David Thompson, Clarity Compliance

11:30 - 11:50 The Big Bang Theory: Combining Earned Value, Agile Project Management and Principle Agent Theory for Clinical Trials
Roger Joby Bsc. CSi CertMgmt MAPM, 1to1to1 part of R. & N.R. Consulting - Institute of Clinical Research

11:50 - 12:10 What’s Changing with ICH-GCP
Dr Alison Messom, ICR

12:10 - 12:30 The Clinical Trial Regulation in a Nutshell
Mark Richardson, ICR

14:00 - 14:20 An Introduction to the GxP Cloud: Risks, Regulatory Considerations and Vendor Assessment
Keith Williams, Managing Director - Formpipe

14:20 - 14:40 The Path to Predictability in Life Science Supply Chains
Sean Robinson, Astec IT Solutions

14:40 - 15:00 OEE /SPC with Operational Excellence
Garry Smith, CIMLogic

15:45 - 16:45 Where on Earth are Your New Ideas Going to Come From? Cross-Industry Innovation for Pharma and Healthcare
Dr Malcolm McKechnie, iFormulate
Dr David Calvert, iFormulate
Dr Jim Bullock, iFormulate

26 April – Room B

09:15 - 09:35 How the EXCiPACT Certification Scheme helps you comply with the Ascertaining GMP for Excipients Guidelines
Iain Moore, Croda

09:35 - 09:55 How the EXCiPACT™ Certification Scheme is helping excipient suppliers with the increasing demands for audits: – the suppliers view
Iain Moore, Croda

09:55 - 10:15 How the EXCiPACT™ Certification Scheme is helping excipient suppliers with the increasing demands for audits: – the users view
Tony Scott

12:00 - 12:30 Aqueous Ready-to-use Film Coating Formulation Based on HPMC-AS
Dr Mahmud Yunis, Biogrund

14:00 - 14:20 Novel Excipients from Kerry for Product Development
Szilard Borbely, Technical Manager, Excipients - Kerry Ingredients

14:20 - 14:40 Skin Feel Modification for Topical Formulations
Richard Summers, Technical Product Manager - Azelis UK Life Sciences

14:40 - 15:00 Applications Using a Multi Functional Excipient, L-HPC
Shilpa Mistry, Shin Etsu

15:45 - 16:05 Dermopharmacy
Kathleen Allain, SEPPIC

26 April – Room C

09:15 - 09:45 Factors to Consider when Designing a Disinfectant Efficacy Test
Rachel Blount, Ecolab Contamination Control

09:45 - 10:15 Microbiological Aspects of Risk Assessment in the Plant
Andy Martin, Director - ABM Consulting Ltd

11:30 - 11:50 An Approach to Process Development of pMDI’s Using Cold Fill and Pressure Fill Technology
Steve Haswell, Process Development Specialist - 3M

11:50 - 12:10 Manufacturing Risk Identification in Facilities Shared for Different Products: a Toxicologist’s Viewpoint
Chris Collins, Q Scientific Consulting Ltd

12:10 - 12:30 Closures Advantaged Technology: Managing Closures on the Filling Line Process
Cristina Testoni, Steelco Group
Stefano Beni, Steelco Group

14:00 - 14:30 Sterile Process Connections
Craig Forrester, Staubli (UK) Ltd

14:30 - 15:00 The True Cost of Water
Kalpesh Shah, Veolia

15:40 - 15:05 Serialisation
Grainne Hughes, Operations Manager - ALMAC

16:05 - 16:25 Early Access to Innovative New Medicines – a Continually Evolving Environment
Mark Corbett, Independent Pharmaceutical Consultant

16:25 - 16:45 The Role and Responsibilities of a QP (Revision of EU GMP Annex 16)
Mukesh Patel, CommQP

16:45 - 17:15 Scale-Up in Tablet Production
Ingo Krause, S3 Process

26 April – Room D

09:15 - 09:35 The Supply Chain and the Impact of Operational Excellence
Track: IMechE, Operational Excellence, Pharmaceutical Engineering
Clare Edwards, GSK

09:35 - 09:55 Operational Readiness Leading to Excellence
Track: IMechE, Operational Excellence, Pharmaceutical Engineering
Adrian Mills, Strategic Projects and Engineering Soutions Limited

09:55 - 10:15 Effective Equipment Reliability in FMCG
Track: IMechE, Operational Excellence, Pharmaceutical Engineering, Processing
Alicia Sanchez Espin, GSK
Marcus Valance, GSK

11:30 - 11:50 Contamination Control
Track: IMechE, Operational Excellence, Pharmaceutical Quality
Chris Hurst, Head of Engineering Compliance - GSK

11:50 - 12:30 Avoidance of Physical Contamination
Track: IMechE, Operational Excellence, Pharmaceutical Quality
David McFarland, GSK

14:00 - 14:20 Continuous Processing
Track: IMechE, Pharmaceutical Engineering, Processing
Peter Hewitson, Brunel University

14:20 - 14:40 The Serialisation Solution – What Does it Offer to Continuous Processing? What is the Potential When Looking at Continuous Processing?
Track: IMechE, Packaging, Pharmaceutical Engineering, Processing
Peter Iles-Smith, GSK

14:40 - 15:10 Continuous Processing Chromatography: Purification of Monoclonal Antibodies
Track: IMechE, Processing
Flemming Carlsen, Sales Director - Lewa Process Technologies

16:05 - 16:25 Quality Considerations / The Importance of Containment
Track: IMechE, Pharmaceutical Engineering, Pharmaceutical Quality
Iain Skinner, Skinner Associates Ltd

16:25 - 16:40 Quality Considerations / Human Factors
Track: IMechE, Pharmaceutical Engineering, Pharmaceutical Quality
Karen Stevenson