Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
08:00 - 08:55 55 mins
Stability and AMDVT
Registration and Morning Coffee
08:55 - 09:05 10 mins
Stability Testing for Pharmaceuticals
Chairperson's Opening Remarks
  • Christopher Riley - President, Riley and Rabel Consulting Services Inc., USA
more
08:55 - 09:05 10 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
Chairperson's Opening Remarks
  • Elena Razzano - Senior Pharmaceutical Assessor, Licencing Division, MHRA, UK
more
09:05 - 09:40 35 mins
Stability Testing for Pharmaceuticals
ICH Guidelines and Current Expectations from the Regulatory Perspective
  • Raquel Figueiredo - Stability and Validation Specialist Quality Department , BIAL, Portugal
more
  • Feedback on the current ICH landscape for stability
09:05 - 10:05 60 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
An update on current QbD regulatory expectations
  • Elena Razzano - Senior Pharmaceutical Assessor, Licencing Division, MHRA, UK
more
  • Application
  • DoE on experiments
  • QbD in an analytical setting vs. a production setting
  • Filing expectations
09:40 - 10:15 35 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
DoE: a statistical approach to optimize ESI-MS parameters for routinely quantitative estimation of a protein glycosylation pattern
  • Patrizia Simone - Associate Researcher, Merck Serono, Italy
more
09:40 - 10:15 35 mins
Stability Testing for Pharmaceuticals
Discussion Panel: Industry Interpretations of ICH Guidelines
  • Kailash Chandra Asati - Senior Stability Expert, Scientific Support, TRD-ARD, Novartis Healthcare, India
  • Horst Kastrup - Senior Regulatory Advisor, Meda Pharma
more
  • ICH 1QE
  • Interpretation on the ICH guidelines book
  • Implementation of ICHQ3D
  • Anti-counterfeit directive
  • Stability for where there are little or no guidance documents: i.e. shipping studies
  • What does it take to become a stability indicating method?
  •  Container closure integrity
10:15 - 10:45 30 mins
Stability and AMDVT
Rapid, material sparing method to predict shelf life for early stage API candidates
  • Mike Lopez - Executive Director, Reaction Analytics, USA
more
10:45 - 11:15 30 mins
Main agenda
Morning Coffee and Networking
11:15 - 11:50 35 mins
Stability Testing for Pharmaceuticals
Strategies for Qualification of Impurities in Generic Medicinal Products
  • Ema Kikovska-Stojanovska - Microbiology and In silico Toxicology, Alkaloid AS Skopje, Macedonia
more
  • Case study
  • How do you investigate the root cause?
  • What are the consequent steps?
11:15 - 11:50 35 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
Case Study: Method Development Using QbD
  • Cyrille Chery - Principal Scientist, UCB Pharma, Belgium
more

QbD principles applied to the development of a capillary gel electrophoresis (CGE) purity & impurity assay focusing on the different steps: Analytical Target profile (ATP) definition, Technology selection, Risk Assessment methodology, Design of Experiments (DoE), Method Validation (Total Error approach) and Control Strategy.

11:50 - 12:50 60 mins
Stability Testing for Pharmaceuticals
Identifying Out of Trend Batch to Batch
  • Horst Kastrup - Senior Regulatory Advisor, Meda Pharma
more
  • How do you identify out of trend?
  • What happens when the out of trend occurs batch to batch for the same product?
11:50 - 12:25 35 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
Discussion Panel: The Conflict Between QbD and Phase Appropriate Validation
  • Cyrille Chery - Principal Scientist, UCB Pharma, Belgium
  • Elena Razzano - Senior Pharmaceutical Assessor, Licencing Division, MHRA, UK
more
  • A look at the contrast between both concepts
  • Which is right?
  • What will be the expectations moving forward?
12:15 - 12:45 30 mins
Stability Testing for Pharmaceuticals
“Organic Impurity Profiling” for Drug Products versus (screening) “Leachable Studies”: What Is There to Learn?
  • Lise Vanderkelen - Department Head Pharma Services, Toxikon, Belgium
more

Organic Impurities, especially genotoxic impurities, are critical quality attributes of drug substances and drug products because they have the potential to affect the safety and efficacy. The origin of the impurity may also determine which guidelines (and associated control limits) to follow in the final evaluation of the drug impurity. The scientific results of Leachable Studies, and in particular “screening” leachable studies, may assist in establishing a broad organic impurity profile for drug products, at low concentration levels. It is clear that only by knowing the unknowns, you will gain control.

12:55 - 14:10 75 mins
Main agenda
Lunch and Live Labs
14:10 - 15:20 70 mins
Stability Testing for Pharmaceuticals
Dual Dialogue: Challenges of Analytics for Generic Products
  • Elisabeth Kovacs - CSO Chemistry and Analytical Sci., Apotex Inc., Canada
more
  • Practical feedback on developing analytical methods in a generic environment
  • Old Vs. New methods for a legacy product
  • When do you need to update methods, and what does this mean?
14:10 - 14:45 35 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
Teleconference: Validation of Analytical methods and Analytical Transfers for Pharma
  • BM Rao - VP and Head Corporate Quality Control, Dr Reddy’s Laboratories Limited, India
more
  • Current Regulations and Quality Standards
  • Parameters and Tests for Method Validation
  • Method Validation Process
  • Method Adjustments, Changes Revalidation, and Verification of Standard and Compendial Methods
  • Transfer of Analytical Methods - Challenges
  • Handling pharmacopeial changes and contributing to monographs (advantages and challenges)
14:45 - 15:20 35 mins
Analytical Method Development, Validation and Transfer for Pharmaceuticals
Analytical method validation based on total error
  • Harry Yang - Senior Director, Medimmune, USA
more
15:20 - 15:50 30 mins
Stability and AMDVT
A high throughput approach to excipient screening in early formulation development
  • Fredrik Lehmann - General Manager and Sales Director, Preclinical and Chemistry Services, Recipharm, Sweden
more

Many compounds both in early and late stage development suffers from fairly low solubility making it time and cost consuming to develop formulations for early in-vivo studies, such as pk, efficacy and tox studies. Historically and even up till this day, early formulation development does often follow a manual trial and error approach. We have in contrast developed a high throughput approach to early formulation. This reduces timelines to a matter of a few days and also keeping the need for API in the low mg amount.

15:50 - 16:20 30 mins
Main agenda
Afternoon Coffee Break
16:20 - 16:55 35 mins
Stability and AMDVT
Application of QbD to Stability Prediction of Drug Dissolution from Immediate Release Tablets and its Utility for Moisture Control Strategy
  • Christopher Riley - President, Riley and Rabel Consulting Services Inc., USA
more
  • Analytical quality by design for prediction of changes in dissolution
  • Application of ASAP prime software
  • Moisture control strategy to optimize packaging configuration and drug product specification
16:55 - 17:25 30 mins
Stability and AMDVT
Predict Bio-product Shelf-life by Using Stability Modeling - Evaluate Impact of Temperature Excursions from the “Cold Chain”
  • Didier Clenet - Sr. Scientist, Formulation & Stability Platform , Sanofi Pasteur, France
more
17:30 - 17:35 5 mins
Stability and AMDVT
Chairperson's Closing Remarks
  • Christopher Riley - President, Riley and Rabel Consulting Services Inc., USA
more
17:40 - 18:25 45 mins
Stability and AMDVT
Closing Plenary Session: Rosetta Lander – Philae: A Long-Term Space Project to Land on a Comet
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
more

Philae is a comet Lander, part of the ESA Rosetta Mission to comet 67P/Churyumov-Gerasimenko.  After about ten years of development and a ten-year cruise through the solar system it successfully landed on the nucleus of the comet on November 12th, 2014.

Since the anchoring harpoons, which were expected to fix the lander to ground, did not work, Philae bounced in the low gravity environment, and only came to rest after a 2 hour’s “hop” in an unforeseen area on the comet surface.   Fortunately, the scientific instruments, including cameras, mass spectrometers, a magnetometer and a radar instrument could be operated, and fascinating, unprecedented scientific results have been obtained from the surface of an active comet.

Interplanetary space missions, including a long development phase and elaborated qualification tests do have similarities with pharmaceutical research, where time-spans between the concepts for a new drug until readiness for marketing can be similar.

Rosetta is an ESA mission with contributions from its member states and NASA. Rosetta's Philae Lander is provided by a consortium led by DLR, MPS, CNES and ASI with additional contributions from Hungary, UK, Finland, Ireland and Austria.