February 15-16, 2011 | Frankfurt, Germany
Overview
The conference will focus on:
Fast Track in Formulation Development
Fast Track in Sterile Clinical Trial Material Manufacturing
Safety Issues in Manufacturing Biopharmaceutical Clinical Supplies
Clinical Trial Material Packaging and Distribution Challenges
Batch Size Challenges
Regulatory Issues and Developments
You Will Learn
Attending this conference will help ensure you stay abreast of
formulation development concepts
dealing with sparingly soluble drug substances
development issues of biotechnological products
high potency / containment practices
ultimate formulation, manufacturing and equipment technologies
disposables / single use alternatives
container components (ready-to-fill/ ready-to-use) concepts
regulatory requirements
safety (particulates, microbiology)
analytical validation (process, analytics)
risk assessment practices
stability issues (data, shelf life)
issues in packaging, distribution, logistics of clinical trial materials
impact of the Bio IMPD guideline
dealing with GCP, GLP, GMP interaction and interfaces
Who Should Attend
The conference is centered around parenteral clinical trial material manufacturing. It is aimed at the advanced practitioner. It will offer to the beginner an overview on the issues and to the expert an up-date on latest technologies and solutions. The advanced scientist and experienced technician, who are interested in benchmarking their operations and/or are in search of improved practices and technologies will also benefit from attending. Participants will include
professionals directly involved in Clinical Trial Material manufacturing and control
professionals from shop floor to managers
small to large companies
development, manufacturing, control and documentation subject matter experts
Scientific Planning Committee (tentative)
Siegfried Schmitt, Parexel, UK
Marianne Oth, Eli Lilly, BE
Karoline Bechtold-Peters, Boehringer-Ingelheim, D
Tom Thorpe, Afton Scientific, USA
Sue Mann, Sue Mann Consultancy Ltd., UK
Nicolas Butz, Eli Lilly, F
Andreas Neubert, IDT Biologika, D
Karen Ginsbury, PCI, Israel
Joachim Leube, BayerHealthcare, I
Robert Schnepf, Merck KGaA, D
Volker Eck, PDA Europe
Jean-Louis Saubion, Uni Bordeaux, F
Clinical Trial Material 2011 - Fast Track Development and Manufacturing Opportunities
Take the opportunity to learn more about Fast Track opportunities in development and manufacturing of Clinical Trial Material. This conference will guide you through a multitude of aspects to consider. Topics and lecturers confirmed include but are not limited to:
Fast Formulation and Process Development for First-in-Human Products
lectured by Karoline Bechtholdt-Peters, Boehringer-Ingelheim, Germany
EU Regulations and Guidances for Biotech IMPs and National Implementations: GMP Issues and Fast Track Concepts
Regulatory Body lecturer invited
Injectable Formulations for Fast Early Stage Development: Practice and Perspective
Gerrit Hauck, Sanofi-Aventis, Germany
Parenteral Formulation Development for Poorly Water-Soluble Drugs
Mark Saunders, Kluecept, UK
Fast Formulation Development of a Biopharmaceutical in Early Stage
Hanns-Christian Mahler, Roche, Switzerland
Developing Sterile Manufacturing of Highly Potent Investigational Medicinal Products in Early Phase Clinical Studies
Maxime Laugier, MP5/Creapharm, France
Orphan Drugs in High Speed Development
Remco de Vrueh, ZonMW, The Netherlands
Process Efficiency Optimisation of a Freeze-Drying Process
Thomas de Beer, Ghent University, Belgium
Disposables / Single Use Materials in Parenteral Drug Product Manufacturing for Clinical Use
Nils Engel, Boehringer Ingelheim, Germany
Container-Closure System Selection and Issues in Formulation Development
Claudia Petersen, Gerresheimer, Germany
Innovative concepts for flexibe isolators in small scale formulation development
Hans-Juergen Baessler, Skan, Switzerland
Qualification vs. Validation of Manufacturing Processes in Early Stages (DS and DP)
Andreas Neubert, IDT Biologika, Germany
Clinical Trial Material Manufacturing and Product Consistency in the Biotech Industry
Tatyana Touzova, Biolex Inc., USA
Critical Issues and Deviation Management on Storage and Dispatch of sterile IMP solutions
Bernhard Ott, Fresenius-Kabi, Germany
Shipping, Storage and Distribution: The Complex Logistics around Clinical Trials - a CRO perspective
Anthony Frankland, Fisher Clinical Services, UK
How to address Logistics Issues with Clinical Trial Material
Siegfried Schmitt, Parexel, UK
The Role of the Qualified Person in Fast Track Development
Sue Mann, SueMannConsultancy, UK
Quality Agreements in Clinical Trial Material Manufacturing
Thomas Thorpe, Afton Scientific, USA
