Friedrichstraße 151, 10117, Berlin, Germany#AMD2014
September
9
Analytical Method Development, Validation and Transfer
Tuesday 9 September, 8:30 AM 2014 to Wednesday 10 September, 6:00 PM 2014
Friedrichstraße 151, 10117, Berlin, Germany (View Map)
The main objective of the conference is to facilitate industry benchmarking, practical discussions and regulatory agency feedback to enable faster and more effective analytical method development, validation and transfer.
Speaker Faculty:
Simeon Gill, Pharmaceutical Assessor, MHRA, UK
Anders Karlsson, Associate Director, Analytical Science, Pharmaceutical Development, AstraZeneca R&D Mölndal, Sweden
Annick Gervais, Director, Physico-Chemical Method Development, Analytical Sciences for Biologicals, UCB, Belgium
Annette Lauridsen, Associate Director, Analytical Technology, Biogen Idec, Denmark
Maria Baltussen, Head Analytical Research, Synthon, The Netherlands
Thomas Meissner, Head QC Biologics, Novartis Pharma AG, Switzerland
Glen Hodge, Senior Principal Scientist, Pfizer, UK
Adrian Clarke, Fellow, Chemical and Analytical Development, Novartis Pharma AG, Switzerland
Ingvil Gausemel, Senior Scientist, GE Healthcare, Norway
PLUS many more!
Schedule
September 2014
09
10
08:30 to
08:50
Registration opens
08:50 to
09:00
Opening remarks from the Chairperson
09:00 to
09:35
Evaluating current industry submissions and making recommendations for improvement
• Outlining agency requirements and expectations for successful analytical method
validation
• Successfully validating against ICH Q2: How much validation and when in development?
• Discussing regulatory expectations for method transfer
Simeon Gill, Pharmaceutical Assessor, Medicines and Healthcare Products
Regulatory Agency (MHRA), UK
validation
• Successfully validating against ICH Q2: How much validation and when in development?
• Discussing regulatory expectations for method transfer
Simeon Gill, Pharmaceutical Assessor, Medicines and Healthcare Products
Regulatory Agency (MHRA), UK
09:35 to
10:10
10 key considerations for improving applications supporting analytical procedures and method validations
• Varying extents of validation throughout clinical development
• Meeting validation criteria for successful regulatory approval
• Outlining regulatory expectations for testing and demonstrating analytical method
robustness
• Developing lean methods whilst meeting regulatory expectations and requirements
Dr Alfred V. Del Grosso, Team Leader, Chemistry, U.S. Food and Drug
Administration (FDA), Center for Biologics Evaluation and Research, Division of
Biological Standards and Quality Control, USA
• Meeting validation criteria for successful regulatory approval
• Outlining regulatory expectations for testing and demonstrating analytical method
robustness
• Developing lean methods whilst meeting regulatory expectations and requirements
Dr Alfred V. Del Grosso, Team Leader, Chemistry, U.S. Food and Drug
Administration (FDA), Center for Biologics Evaluation and Research, Division of
Biological Standards and Quality Control, USA
10:10 to
10:45
Morning coffee, networking and exhibition viewing time
10:45 to
11:20
Examining the concept of validation lifecycle management of analytical procedures
• Application of QbD principles to pharmaceutical analysis
• EFPIA/PhRMA White Paper, USP Stimuli Article (PF 39/5)
• Establishment of measurement requirements: Analytical Target Profile
• 3-Stage-Approach to analytical validation:
– Method Design
– Method Performance Qualification
– Continued Method Performance Verification
• Change Control and regulatory flexibility
Dr Joachim Ermer, Head of Quality Control Services, Frankfurt Chemistry & Global Reference
Standards Coordinator, Sanofi, Germany
• EFPIA/PhRMA White Paper, USP Stimuli Article (PF 39/5)
• Establishment of measurement requirements: Analytical Target Profile
• 3-Stage-Approach to analytical validation:
– Method Design
– Method Performance Qualification
– Continued Method Performance Verification
• Change Control and regulatory flexibility
Dr Joachim Ermer, Head of Quality Control Services, Frankfurt Chemistry & Global Reference
Standards Coordinator, Sanofi, Germany
11:20 to
11:35
Discussing regulatory acceptance of QbD style submissions for QbD in analytics: MHRA and European stances
Simeon Gill, Pharmaceutical Assessor, Medicines and Healthcare Products Regulatory
Agency (MHRA), UK
Agency (MHRA), UK
11:35 to
11:50
New (2014) FDA CDER/CBER Draft Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics
Dr Alfred V. Del Grosso, Team Leader, Chemistry, U.S. Food and Drug Administration
(FDA), Center for Biologics Evaluation and Research, Division of Biological Standards
and Quality Control, USA
(FDA), Center for Biologics Evaluation and Research, Division of Biological Standards
and Quality Control, USA
11:50 to
12:25
Case study: Demonstrating successful development, validation and transfer of a supercritical fluid chromatography (SFC) impurity method for a late stage oncology candidate
For full details, visit www.informa-ls.com/AMD
Dr Claudio Brunelli, Senior Scientist, Pfizer Analytical Research and Development, UK
Dr Claudio Brunelli, Senior Scientist, Pfizer Analytical Research and Development, UK
12:25 to
13:00
Case study: Utilising a control strategy concept for the development of analytical QC methods
• Demonstrating method robustness with a control strategy based concept for analytical
methods
• Discussing continuous improvement possibilities in relation to a control strategy concept
• Illustrating what a control strategy based concept for analytical methods looks like in
practice
• Determining key features of control strategy based analytical methods
• Assessing what signifies major and minor method changes
Silke Klick, Regulatory CMC Director, AstraZeneca R&D;, Sweden
methods
• Discussing continuous improvement possibilities in relation to a control strategy concept
• Illustrating what a control strategy based concept for analytical methods looks like in
practice
• Determining key features of control strategy based analytical methods
• Assessing what signifies major and minor method changes
Silke Klick, Regulatory CMC Director, AstraZeneca R&D;, Sweden
13:00 to
14:00
Break Time
14:00 to
14:35
Examining the characterisation of primary references: An industry case study concerning a new drug, Vizamyl
• Addressing the substances used: Drug Substance and Final Intermediate
• Assessing which parameters have been covered, and why
• Examining the rationale behind why parameters were dropped
• Balancing the need for investigating all parameters on the primary reference vs
technical quality
• Do we use results from early phase research in the primary reference characterization?
• Discussing how much time is spent on primary reference characterization and is this
appropriate
Dr Arnfinn G Andersen, Department Manager, Analytical & Bioanalytical Chemistry
Department, GE Healthcare, Norway
• Assessing which parameters have been covered, and why
• Examining the rationale behind why parameters were dropped
• Balancing the need for investigating all parameters on the primary reference vs
technical quality
• Do we use results from early phase research in the primary reference characterization?
• Discussing how much time is spent on primary reference characterization and is this
appropriate
Dr Arnfinn G Andersen, Department Manager, Analytical & Bioanalytical Chemistry
Department, GE Healthcare, Norway
14:35 to
15:10
Method development for determination of genotoxic impurities by headspace gas chromatography with mass spectrometry detection and sample preparation in ionic liquids
For full details, visit www.informa-ls.com/AMD
Estelle Bour, Analytic Scientist, Analytical Chemistry, F. Hoffmann-La Roche Ltd, Switzerland
Estelle Bour, Analytic Scientist, Analytical Chemistry, F. Hoffmann-La Roche Ltd, Switzerland
15:10 to
15:45
Case study: Demonstrating the use of computer assisted analytical method development in practice
• Addressing how computer methods were integrated into new analytical method
development strategies
• Demonstrating how computer method development can be used on a daily basis
• Sharing examples of method envelopment simulations and predictions
• Examining how data and findings are translated into more effective and efficient real
method development
Adrian Doggett, Research Scientist, Bristol-Myers Squibb, UK
development strategies
• Demonstrating how computer method development can be used on a daily basis
• Sharing examples of method envelopment simulations and predictions
• Examining how data and findings are translated into more effective and efficient real
method development
Adrian Doggett, Research Scientist, Bristol-Myers Squibb, UK
15:45 to
16:20
Afternoon tea, Networking and Exhibition viewing time
16:20 to
17:25
Troubleshooting and experience exchange: Practical advice for successfully transitioning HPLC methods to UHPLC
• Validation requirements when scaling HPLC to UHPLC and vice versa
• Assessing the parameters that need to be monitored for a successful transition between
HPLC and UHPLC but also between different UHPLC systems
• Considerations on system (extra-column) dispersion and tips and tricks to optimise
HPLC/UHPLC systems
• Overcoming common issues of resolution, repeatability and accuracy
• Establishing standard tests for system monitoring and troubleshooting
• Sharing best practices and examples of successful HPLC to UHPLC transitions
Dr Dorina Kotoni, Principal Scientist, Chemical and Analytical Development,
Novartis Pharma AG, Switzerland
Lynne Burrell, Senior Scientist, Analytical Development, GSK, UK
• Assessing the parameters that need to be monitored for a successful transition between
HPLC and UHPLC but also between different UHPLC systems
• Considerations on system (extra-column) dispersion and tips and tricks to optimise
HPLC/UHPLC systems
• Overcoming common issues of resolution, repeatability and accuracy
• Establishing standard tests for system monitoring and troubleshooting
• Sharing best practices and examples of successful HPLC to UHPLC transitions
Dr Dorina Kotoni, Principal Scientist, Chemical and Analytical Development,
Novartis Pharma AG, Switzerland
Lynne Burrell, Senior Scientist, Analytical Development, GSK, UK
17:25 to
18:00
Closing remarks from the Chairperson
Networking drinks in the exhibition hall.
18:00 to
20:15
Developing strategies for effective analytical method lifecycle management
Registration is at 18:00 for a 18:15 start. The seminar will finish no later than 20:15 and will be followed by an evening meal.
Speakers and discussion hosts include:
Sébastien Vion, QC Analytical Expert, Novartis BioPharmaOps, France
Joachim Ermer, Head of Quality Control Services, Frankfurt Chemistry & Global Reference Standards Coordinator, Sanofi, Germany
Speakers and discussion hosts include:
Sébastien Vion, QC Analytical Expert, Novartis BioPharmaOps, France
Joachim Ermer, Head of Quality Control Services, Frankfurt Chemistry & Global Reference Standards Coordinator, Sanofi, Germany
Friedrichstraße 151, 10117, Berlin, Germany
