REPORTS ON JPAG MEETINGS
2000 - 2010

Now in reverse order

3 February 2011
MEASUREMENT CHALLENGES IN THE ANALYSIS OF TOPICAL PRODUCTS

Full meeting report      Presenters' Slides

2 December 2010
CHARACTERISATION OF ACTIVE PHARMACEUTICAL INGREDIENTS

Full meeting report      Presenters' Slides

1 September 2010
ANALYSIS OF DRUG INCLUSION PRODUCTS

Full meeting report      Presenters' Slides

10 June 2010
CRITICAL ISSUES IN THE STABILITY OF PRODUCTS

Full meeting report      Presenters' Slides

22 April 2010
CHEMOMETRICS AND MULTIVARIATE STATISTICS IN PHARMACEUTICAL DEVELOPMENT

Full meeting report      Presenters' Slides

4 March 2010
QUALITY BY DESIGN FOR ANALYTICAL METHODS

Full meeting report      Presenters' Slides

3 December 2009
THE ANALYTICAL SCIENCE AND REGULATION OF PHARMACEUTICAL PACKAGING

Full meeting report      Presenters' Slides

15 October 2009
ANALYSIS OF INHALED PRODUCTS

Full meeting report      Presenters' Slides

6 August 2009
PHARMACOPOEIAL USER FORUM

Full meeting report      Presenters' Slides

11 June 2009
BIOSIMILARS AND ANALYTICAL CHALLENGES

Full meeting report      Presenters' Slides

23 April 2009
IMPACT OF Q8, Q9 AND Q10: Quality by design: fact or fiction?

Full meeting report      Presenters' Slides

5 March 2009
Clinical Trials Directive - 5 years on

Full meeting report      Presenters' Slides

Tuesday 2 December 2008
The current state of dissolution testing

This symposium explored the use of dissolution testing in the development and control of a range of dosage forms. Invited speakers described the pharmacopoeial methods that are available, discussed equipment requirements with respect to qualification and calibration, and provided practical examples of how these methods are used during development and routine quality control. The symposium also discussed the use, regulatory acceptance and further development of the Biopharmaceutics Classification System and described how it may be used to justify “biowaivers”. Setting specifications for modified release products was discussed and supported by examples of in-vitro – in vivo correlations (IVIVC) and how this can support post-approval changes.

Full meeting report      Presenters' Slides

This report also appeared in the Pharmaceutical Journal. 17th January 2009 vol 282 pp52-54

Thursday 16 October 2008
Advances in pharmaceutical laboratory efficiency

The QC Laboratory, in both the R & D and Operations environment, is a key element of the supply chain and has a particularly significant impact on lead times, affecting speed of drug development and overall site manufacturing performance. As the UK pharmaceutical industry faces ever-increasing competition from abroad, the enhancement of laboratory productivity to improve the product-process development cycle and manufacturing efficiency has become even more crucial for the long-term viability of UK-based sites. This symposium reviewed advances in laboratory efficiency which, both individually and collectively, are designed to achieve these outcomes, through the adoption of process-based improvement tools, automation and integrated data handling within the laboratory.

Full meeting report           Presenters' Slides

This report of the meeting also appeared in the Pharmaceutical Journal 1 November 2008 volume 281 pp 517-518

30 September 2008
JPAG at FACSS Reno, Nevada 2008

NIR Spectroscopy in Pharmaceutical Analysis: Technology Transfer in Action

Organised for FACSS by the Joint Pharmaceutical Analysis Group (JPAG) of the Royal Society of Chemistry (RSC), this meeting gave the current situation and describe methods in the successful transfer of NIR libraries, calibrations and PAT methods from instrument to instrument.

JPAG at FACSS 2008         CASA 2006 at FACSS 2008

7 - 9 September 2008 15.00 - 17.00
JPAG contributions within British Pharmaceutical Conference 2008

Sunday 7 September 2008
Short papers in pharmaceutical analysis

Including the JPAG 'Conference Analytical Science Award' with bursary up to £2000 for best presenter aged under 35. This years award was made to Louise Ho

JPAG at the BPC          CASA 2008

Monday 8 September 2008
Comparability of medicines (in association with APSGB Biologics Focus Group)

The complexity of new molecular entities and their delivery systems presents an increasing challenge to scientists and regulatory agencies alike in establishing the comparability of drug products arising from manufacturing changes or new commercial sources. This symposium examined the regulatory and analytical aspects of characterising change in the assessment of product safety and performance.

Thursday 12 June 2008 - Combating counterfeit medicines - the challenge for the analyst

Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50%. One prediction is that global counterfeit drug sales will reach $75 billion by 210. This symposium looked at methods to detect counterfeit medicines, the current and prospective legislative position, and ways to combat counterfeiting. The exhibition presented relevant equipment and systems to detect and combat counterfeit medicines, and there was a small poster display.

PJ Report        Presenters' Slides and Poster Abstracts

Thursday and Friday 3-4 April 2008 - Faster and Smarter Analysis

The pharmaceutical sector is under increasing commercial and social pressure to discover and develop important new medicines while reducing cost and improving productivity. This conference will explore how technology developments in analytical spectroscopy, separation science and laboratory automation and informatics can help to achieve these goals through faster – or smarter – analysis in order to gain more information per test.

HTML version        PDF version        Presenters' Slides

Thursday 13 December - Trace analysis & challenges for high sensitivity methods

A major challenge faced by pharmaceutical analysts throughout the industry has always been the detection of substances present at very low concentration. Often the substances are impurities that may arise from the raw materials or be generated in the process and left behind as residuals. Increasingly these days, the drug product may be so potent that very small doses are required and these must be accurately assayed. The symposium at the London School of Pharmacy provided a unique opportunity to bring together the views of experts with particular interests in high sensitivity detection methods.

PJ Report        Presenters' Slides

Thursday 11 October - Risk Assessment in Pharmaceutical Research, Development and Manufacture: The Measurement & Management Challenges

What drug industry representatives think about risk assessment in analytical applications and specific risk areas was the theme of the meeting on risk management held at Church House, London
PJ Report        Presenters' Slides

Monday 10 - Wednesday 12 September 2007
JPAG at the British Pharmaceutical Conference

mini-symposium 1: ‘Risk management as a key to pharmaceutical quality’
mini-symposium 2: ‘Analysis of herbal products’
Sessions for reading 'Short papers in pharmaceutical analysis'
JPAG ‘Conference Analytical Science Award’ with bursary up to £2,000 for best presenter aged under 35
Reducing the risks of counterfeiting

See also the Pharmaceutical Journal Supplement for the BPC 2007

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Wednesday 2 May - Analytical support for clinical trials: meeting clinical and regulatory needs

An audience of hospital pharmacists, Qualified Persons and sponsors from the pharmaceutical industry heard presentations at a recent meeting on how clinical trials rely on analytical support the Society's London headquarters.

Thursday 22 March 2007 - The role of materials characterisation in pharmaceutical quality by design and manufacture
a complement to December 2006 symposium

Material characterisation techniques play an increasingly central role in product and process understanding. The latest developments in these techniques and their applications were reviewed in a symposium organised by the Joint Pharmaceutical Analysis Group in association with the Academy of Pharmaceutical Sciences at the London School of Pharmacy on 22nd March.

7 December 2006 - Material functionality and fitness for purpose in solid dosage forms

In the drive to make more reliable and efficient processes and effective products, industry is increasingly realising the importance that controlling the properties of the input materials, including both the active pharmaceutical ingredient and excipients, has in achieving these objectives.

4-6 September 2006 - The British Pharmaceutical Conference

The Joint Pharmaceutical Analysis Group had a significant presence at the British Pharmaceutical Conference, organising two mini-symposia and the oppportunity for less-experienced analysts to present their work to an international, but sympathetic audience.

15 June 2006 - Analysis of modified release dosage forms

The meeting provided an insight into the analysis of modified release products, covering imaging of multi-particulates, characterisation of temperature-responsive polymer systems, characterisation of excipients and consider aspects of process analytical technology and quality-by-design. It also discussed the future of dissolution testing and provided case studies on the development of in vitro - in vivo correlations.

29 March 2006 - Changing regulatory requirements in active pharmaceutical ingredient manufacture and control

The meeting examined the manufacture and control of Active Pharmaceutical Ingredients (API)with emphasis on new and evolving regulatory requirements. The programme included perspectives from opinion leaders in the pharmaceutical industry and regulatory agencies, together with an interactive panel session for audience questions.

8th December 2005 - Intelligent Method Development

Method validation is covered in scientific meetings and courses far more frequently than is method development, yet the development phase is very important because if the method foundations are not strong, then validation can only confirm that fact; it can not improve the method. The one-day symposiumexplored best practices for the intelligent development of informative, robust methods.

13th October 2005 - Developments in Near Infrared Spectrometry in Pharmaceutical Analysis

Practising pharmaceutical analysts specialising in near-infrared spectroscopy gathered with regulators and teachers seeking a better appreciation of what NIRS can offer to examine and discuss the current state of the art of the technologies and applications.

19 May 2005 - One year on: the impact of the EU Clinical Trials Directive

The EU Clinical Trials Directive (2001/20/EC) was implemented across Europe by 1st May 2004. One year on, this symposium aimed to review the legislation on applications for clinical trials, the manufacture and release of investigational medicinal products and the conduct of clinical trials. The programme included experiences from the pharmaceutical industry, the National Health Service and regulatory bodies in the UK annd in mainland Europe.

17 March 2005 - Charge-based Separations in Pharmaceutical Analysis

In a one-day update symposium, the technologies and applications of charge-based separations in pharmaceutical analysis were examined by leading experts from industry, academia and the regulatory authorities.

2 December 2004 - Genomics, Proteomics and Metabonomics in Drug Discovery and Development

New analytical technologies in genomics, proteomics and metabonomics are changing historic approaches to pharmaceutical research and development. The number of successful new drug registrations is falling, whereas development costs continue steadily to rise. Genomics has not yet delivered but new discoveries in systems biology involve heavy investment and business is leading science. The meeting dealt with the tools and applications of transcription and an international slate of speakers provided an overview of these new techniques and their various applications in drug development.

20 May 2004 - Method Validation and Measurement Uncertainty in the Pharmaceutical Industry

Whilst ICH validation guidelines provide a framework for the core activity of measurement validity, actual requirements are heavily influenced by the purpose and uncertainty of the measurement. A one-day symposium organised by the Joint Pharmaceutical Analysis Group at the Royal Pharmaceutical Society London on the 20th May 2004 examined key strategies for the successful validation of analytical methods at all stages of a medicine's life, from clinical trials through to post-marketing.

18 March 2004 - The Contribution of Analytical Science to Rapid Microbiological Assessment

Rapid microbiological methods offer substantial advantages over conventional microbiological methods and could endow significant advantages on the pharmaceutical industry for product quality control and process analytical technology. A meeting organised by the Joint Pharmaceutical Analysis Group at the Royal Pharmaceutical Society London on the 18th March 2004 reviewed the techniques available and discussed technical and regulatory issues surrounding the use of rapid microbiological methods.

12 and 13 February - BIOVAL 2004 - Towards a Concencus on Validation of Bioanalysis Methods for Large Molecules

A recent international conference in London considered progress towards regulatory guidance for validation of analytical methods for the quantitation of macromolecules in biological fluids, for assessment of antibodies and for validation of biomarker assays. The meeting was organised by the Joint Pharmaceutical Analysis Group at the Royal Pharmaceutical Society London.

4 December 2003 - Process Analytical Technology (PAT): The Challenge for Analytical Science and the Analyst

The science base underpinning pharmaceutical development and manufacture has failed to keep pace with available technology. The drivers, means and benefits of adopting a process analytical technology strategy, its facilitation in the regulatory environment and its impact on analytical science and the analyst were reviewed in a workshop held by the Joint Pharmaceutical Analysis Group at the Royal Pharmaceutical Society London on the 4th December 2003.

8 May 2003 - Control of impurities and degradation products

The increasing need to identify impurities quickly, and to select efficient test procedures, offers continuing challenges for the pharmaceutical analyst, including maintaining awareness of rapidly evolving regulatory requirements. Experts from industry and regulatory agencies reviewed these issues in a symposium organised by the Joint Pharmaceutical Analysis Group at the Royal Pharmaceutical Society London on the 8 May 2003.

13 March 2003 - Regulatory status and analytical challenges of gene therapy

Quality control and safety issues of gene therapy offer uniquely new challenges to the pharmaceutical analyst. The background of gene therapy research and development and the emerging analytical problems were explored in a symposium organised by the Joint Pharmaceutical Analysis Group and the Hospital Pharmacists Group at the Royal Pharmaceutical Society London on the 13 March 2003.

5 December 2002 -What you would like to know about the control of active pharmaceutical ingredients - but were afraid to ask!

The publication of Annex 18 of the EU Guide to GMP formally brought APIs (active pharmaceutical ingredients) within the scope of GMP. The regulatory authorities and industry have been engaged in a voluntary inspection programme using the relevant guidelines of the International Conference on Harmonisation on which the Annex is based. Dr Geoffrey Sharpe chaired a meeting organised by the Joint Pharmaceutical Analysis Group and held at the Royal Pharmaceutical Society, London on 5 December to discuss experience of the voluntary inspection programme and the implications for monograph development for the official pharmacopoeias

6th November 2002 - An Industrial Perspective of Method Validation and Measurement Uncertainty joint meeting of JPAG with RSCAD/NWR at Runcorn Heath.

The seminar provided analytical chemists from all industries, at both multinational and small to medium size enterprise level, an informative, cost effective update on best practice in method validation and uncertainty to meet both in-house and external regulatory requirements. Presentations aimed is to give practitioners insight into how best to confer validity, reliability and a level of uncertainty of analysis in a commercial environment.
Method validation- the ICH guidelines approach (AstraZeneca), Regulatory developments driving the demand for Chemical Analysis (LGC), Uncertainty, the UKAS requirements (UKAS), Understanding the validation/uncertainty data- statistics (Avecia Ltd), Small to medium size enterprise perspectives on VAM principles (Octel Corp) Method transfer in the Pharmaceutical Industry (AstraZeneca), Raw material specifications in the Home and Personal Care Business (Unilever)

23rd-24th September 2002 - JPAG Sessions within BPC'02 At Manchester

New Analytical Techniques for the Quality Assurance of Phytopharmaceuticals
Robert Watt (ULSoP), Peter Hylands (Oxford Nat.Prod.), Prof Hubertus Irth (Amsterdam), Mellissa Hanna (KCL)
Short Papers in Pharmaceutical Analysis (7)
Short Papers in Pharmaceutical and Phytochemical Analysis (8)

24th - 25th July 2002 - Acoustic sensors : a two-day conference at the Royal Albion Hotel, Brighton, organised by University of Brighton and RSC, in association with JPAG

Comprised four plenary sessions plus a poster session and preceding technology fair for companies associated with acoustic sensor technologies. It brought together users, manufacturers and those interested in novel technologies from a broad spectrum of academic and industrial backgrounds.
Prof. Michael Thompson (U Toronto), Frank Paul (GSK).

23rd May 2002 - Regulatory Hot Topics: eight challenges for the analytical chemist

From biotechnology to novel delivery systems, the ever-increasing complexity of new drugs provides major technical challenges and opportunities for the pharmaceutical analyst. In this symposium, key areas where analytical science continues to test contemporary regulations (and vice versa) will be reviewed with updates and perspectives from experts in pharmaceutical industry and from British (MCA) and US (FDA) regulatory agencies.
Speakers were - Paul Sugden (Ph Dev Serv), John Bray (Q-One Biotech), Meenu Wadhwa (NIBSC), Cornelia Höhne (PhytoLab, Germany), Rajendra Uppoor (CDER, FDA), Stephen Robinson (Pfizer), Matthew Bonam (AstraZeneca), Bronwyn Phillips (MCA)

28th February and 1st March 2002 - BIOVAL 2002, RPS and JPAG, associated with AcadPhSc, AmAssPhSc, FDA, FIP and EuFedPhSc.

An international Conference with a European Flavour, presented in a workshop that aimed to develop 'Best Practice' on implementing the key issues arising from the draft FDA Guidelines on Bioanalytical Validation for small molecules. Issues encompassed comprised- stability, model evaluation, matrix issues, specificity evaluation, validation acceptability, qualitative and quantitative issues, batch sizes , in process validation, chromatographic acceptability, role of QCs, statistical issues, pharmacokinetic requirements, modified validation requirements, bio-markers, endogenous compounds, determining the LLOQ, Certificates of Analysis.
Kamal Midha (FIP), Vinod Shah (FDA) , Mark Powell (BMS), Ray Briggs (Pharmacia), Steve Pleasance (GSK), Ron Bowsher (Eli Lilly), David Muirhead (Pfizer), Dennis Dell (Consultant), Geoff Houghton (MCA), Howard Hill (HLS), J. Brno (Lilly), J. Burrows (Consultant), Uwe Tinn (Roche), Johan Gabrielson (AstraZeneca).

6th December 2001 - Analytical approaches to speeding drug discovery and development joint with RSC/AD/SE Region [64; Certs 22] [GFP] Pharm.J., (19/1/02),pp.68-69

Old and new analytical technologies are being used to accelerate both drug discovery and subsequent development. Meeting discussed innovating applications using established technologies like HPLC for receptor screening of drug candidates, determination of physicochemical properties, and high throughput pharmacokinetic screening. Newer chip-based technologies have been applied to the discovery of new drug candidates, through to the drug manufacturing process. The resulting proliferation of data must organised, collated, integrated and analysed by new software technologies that can resolve the data bottleneck and provide meaningful, useful conclusions, based on all the contributing data sets.
Prof Chris Atterwill (HLS), Jeff Moore (VertexEurope), Roman Szucs (Pfizer), Darrin Disley (AdaptiveScreening), Coulton Legge (GSK), Richard Storey (Pfizer), Prof Hubertus Irth (FreiUniv.,Amsterdam), Chris Bevan (GSK), and Huw Loaring (InnaPhase Ltd)

23rd-24th September 2001 - JPAG Sessions within British Pharmaceutical Conference 2001 in Glasgow

Analysis of Plant Medicines
Keith Helliwell (Wm.Ransom), Richard Woodfield (MCA), Kevin Volk (BMS,US), Andy Charvill (MCA)
Analytical Methods: Technology Transfer.
Jeff Duke (Pfizer Global R&D), John Andrews (Abbott Pharma), Gerry Maxwell (Huntingdon Life Sciences)
Short Papers in Pharmaceutical Analysis (16 presented orally from 51 posters)

14th June 2001 - The new Clinical Trials Directive : implications for CT supplies

Introduction of the Clinical Trials Directive (CTD) is having a major impact on analysis. GMP requirements (such as batch sizes, raw materials, comparability) will all apply to CT supplies. Controls will be needed for Phase 1, 2 & 3 clinical trials as well as specialist trials (e.g. radio-labelled studies and clinical pharmacology). Consideration must be given to evaluating stability and different validation requirements for accreditation and for application. There are separate issues of transport of supplies (e.g. integrity and safety samples, bio-markers) and the place of the QP in the production of trial supplies is also relevant. All these activities require integrating the rôle of monitor, the investigator, chains of custody, and databases.
Roger Alexander (MCA), Elaine Godfrey (MCA/CTu), Moira Daniels (AstraZeneca), John Blackburn (GSK), Steve Potter (QEH, Birmingham), David Cockburn (Med.Insp.)

8th March 2001 - Current issues and new approaches in pharmaceutical method validation

Validation of emerging and even traditional analytical techniques applied in increasingly novel applications or to novel pharmaceutical products, presents major new challenges for industry and regulatory agencies alike. Successful method validation is critical to Measurement integrity, Timely technology transfer, Successful regulatory approval and Control of development, regulatory and compliance costs. This meeting featured speakers from industry, academia and regulatory agencies, who reviewed contemporary validation guidelines and in particular their utility (or otherwise) in constructing scientifically justified validation plans against this background.
Geoffrey Sharpe (Cobra Therapeutics), Andrew Scott (GSK), Prof Tony Moffat (ULSoP.), Paul Graham (Sanofi Synthélabo), Steve Ellison (LGC), Bob Taylor (SmartTech, Aberdeen), Ray Briggs (Vernalis), Roger Alexander (MCA)

7th December 2000 - Pharmaceutical applications of particle analysis and associated equipment exhibition joint with AD Particle Characterisation Group

Particle size is very important in the pharmaceutical industry: in dry powder inhalers or aerosols, for stability of emulsions or suspensions, in crystal growth or flow properties. There are more and more methods becoming available to monitor particle size; for instance, NIR spectroscopy and acoustic methods have both recently been shown to work in on-line situations. The symposium addressed what factors should inform a choice of method.
Lesley Anderson (MCA), John Sherwood (AstraZeneca), MiWang (Un.Leeds), Carl Sabin (Malvern Instr.), Prof Peter York (Un.Bradford), Nikin Patel (Molecular Profiles), Steve Nichols (Aventis), Gary Nichols (Pfizer).

19th October 2000 - Analysis of Biopharmaceuticals and associated equipment exhibition: joint with AD Analytical Biosciences Group

The expansion in the use of biological products within the pharmaceutical industry, whether as therapeutics, diagnostics or even in potency assays, has meant that many analytical laboratories now deal in some way with biological materials. This symposium, while looking primarily at the analysis of therapeutic products to meet regulatory requirements, brought together traditional testing methods adapted for biopharmaceuticals with novel technology specifically designed for biopharmaceuticals. It interested a diverse audience but was of particular interest to those testing biopharmaceuticals or using materials of biological origin, as well as to QA and regulatory affairs staff involved in their release.
Jim Faulkner (GW), Lincoln Tsang,(MCA), Prof Tudor Arvinte (Novartis Pharma), Alex Drake (KC London), Fiona Greer (M-Scan), Lee Lomas (Ciphergen Biosystems), Roy Cowell (Cobra Therapeutics), Ashvin Patel (GlaxoWellcome)

11th-12th September 2000 - JPAG sessions at British Pharmaceutical Conference, Birmingham

Lab On A Chip Pharm J, 265, 695
The case for, and future of, miniaturisation
Derek Craston (LGC), Jon Cooper, (Glasgow U), Coulton Legge (GlaxoWellcome), Michael Mitchell (ICL), James Jackson (Smart Sensor) The Pharmaceutical Journal Vol 265 No 7121 p695 November 04, 2000 The Conference

Recent Advances in Particle Characterisation.
J Boaler (Oxford Instruments), S Stolnik (Nottingham U), P Kippax (Malvern Instruments), J Sherwood (AstraZeneca), C Washington (Nottingham U)

Short Papers in Pharmaceutical Analysis (16) Pharm.J 265, 422-4

22nd June 2000 - Harmonisation of quality requirements for the registration of medicines. Joint with British Institute of Regulatory Affairs

A harmonised approach to medicines registration requires all appropriate authorities to agree which parameters are important and how these should be tested to show compliance. This symposium examined three critical areas: new drug and compendial specifications; stability testing; and post-authorisation variations; and highlighted the achievements over the previous decade in the global harmonisation of quality requirements. There were two contrasted presentations within each of the three, self-contained, sessions, which provoked lively, interactive and informative discussion.
Chris Potter (AstraZeneca), Andrew French (MCA), Frans Pieters (Organon), Richard Salter (GlaxoWellcome), Krystyna Fielden (MCA) & Chris Dafforn (AstraZeneca)

4th May 2000 - Status of EU Directive on Clinical trials

The topicality of this intended joint meeting with Pharmaceutical Quality Group of IQA was questioned and it was POSTPONED
Consult more recent meetings on this topic at: Clinical Trials Directive 2001

24th February 2000 - Enhancing the current value of established & emerging analytical techniques. MILLENNIUM SYMPOSIUM

The symposium discounted any understating of established 20th century techniques in the 21st century. Important or niche rôles were staked out - including microscopy, modern TLC, and wet chemistry in a contract analysis laboratory. There was a report from a 'Forum' of broadly based analysts that had been considering the recently emerging, but potentially soon mainstream, techniques. The afternoon session explored the advantages offered by advances in optical analysis, NIR imaging, CEC, miniaturisation in the laboratory; and posed the question "How can entry into the 'standard' laboratory be accelerated and resistance, at managerial level or below, be overcome?"
Gary Nichols (Pfizer), Ron Rooney (Rooney Labs.), Alan Howard (Un.Southampton), Prof Tony Moffat (RPSGB), Alex Drake (KC Lond.), Paul Ferguson (IC Lond.), Perry Hailey (Pfizer), Andrew deMello (IC Lond.)