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JPAG - PAST MEETINGS

Here are some of our past meetings:

Thursday 7th December 2017
Ensuring amorphous product quality: what are the challenges?
Royal Society of Chemistry, London
Amorphous drug formulation offers great promise in improving drug solubility - a major challenge in drug development. However, poor physical stability and hard to predict crystallisation remains key barriers for the wider use of amorphous solid solution in the pharmaceutical industry.

This symposium will critically examine the challenges and opportunities lie in the analysis of amorphous formulation systems.
Leading industrialists and academics will be sharing their experiences in the development, manufacturing and quality assurance of amorphous products.
New analytical technologies for the prediction of amorphous stability and novel PAT will be discussed.

You will gain latest knowledges on the analysis and manufacturing of amorphous/solid solution products.
You may form new collaborations with experts across academic and industry.

Speakers:
Prof Gavin Andrews - Queen's University Belfast
Prof Duncan Craig - University College London
Dr Korbinian Löbmann - University of Copenhagen
Dr Claire Pizzey - Diamond Light Source
Hans Platteeuw - Avivia
Dr Paul Royall - King's College London
Dr Abhishek Singh - Johnson & Johnson
Dr Krzysztof Sollohub - Catalent



DETAILS

Tuesday 28th November 2017
The pharmaceutical analysis postgraduate research awards and careers symposium
Royal Society of Chemistry, London
JPAG presents its inaugural pharmaceutical analysis symposium for postgraduate students and early career stage scientists. This will provide the opportunity for delegates to showcase their work and network with peers, academics and industrial scientists through podium and poster presentations.The best podium and poster presentations will be recognised with cash prizes up to 500 GBP.

There will also be plenary lectures by leading scientists and an industrial careers exhibition:

» Professor Melissa Hanna-Brown
Prof Hanna-Brown is Technology & Innovation EU Lead, Pfizer Worldwide R&D, Sandwich, UK and Department of Chemistry, University of Warwick, UK and President of the Analytical Division, Royal Society Chemistry, UK.
» Professor Trevor Jones CBE
Prof Jones is Chairman of the international Clinical Research Organisation, Simbec-Orion, a member of the Boards of the Global Life Sciences investment company; Arix Bioscience; the Oxford based Drug Discovery Company ,e-Therapeutics; and the UK Stem Cell Foundation (UKSCF) .Formerly he was Director of Allergan Inc (USA) and R&D Director of The Wellcome Foundation.

Speakers:
Prof Melissa Hanna-Brown - Pfizer Global R&D
Prof Trevor Jones - King's College London



DETAILS

Thursday 12th October 2017
Stability Challenges III: Assuring the stability of medicines from manufacture to use
Royal Society of Chemistry, London
Continuing our successful Stability Challenges series, this meeting is the third in the series and is aimed at providing the latest information and best practice on many aspects of stability testing. In this particular meeting the focus will be on data evaluation, discussing the estimation and prediction of shelf lives, including physical stability, and the effects of temperature and humidity excursions. Also the efficient application of stability testing according to lean laboratory principles will be explored along with MHRA views on stability requirements and GMDP expectations.

The focus of this meeting is to examine best practice during the distribution and storage of medicines, to ensure correct storage conditions are maintained and to ensure the quality of the medicine is maintained during use in the clinic or by the patient. The generation of data to support temperature excursions and to demonstrate in-use stability will be explored.

This symposium will be of special interest to those engaged in Quality Control and Quality Assurance, pharmaceutical development, regulatory affairs, storage and distribution in the Pharmaceutical Industry, NHS manufacturing units, Contract Research Organisations, consulting, academia, and anyone else concerned with the management and assessment of drug stability.

Speakers:
Dr Paul Whiteside - Pfizer
Miles Ambler - GlaxoSmithKline
Francisco de Matos Afonso Pereira - MHRA
Dr Niels Hartvig - Novo Nordisk
Dr Samuel Kyeremateng - Abbvie
Dr Kristin Lehmkemper - Abbvie
Dr Peter O'Connell - Cuspor
Dr Klimentina Pencheva - Pfizer
Dr Garry Scrivens - Pfizer



DETAILS

Thursday 22nd June 2017
Counterfeit medicines
Royal Society of Chemistry, London
It is now widely accepted that counterfeiting is a huge and growing challenge of global proportion.
This symposium will take an overview of the problems authenticity must address from three different perspectives:
• The problem Globally
• The critical role of Discovery and Compliance
• The key role that authentic APIs play in Risk Management
each of which will be supported by relevant case studies.

Speakers:
Andrew Davies - NHS Improvement
Michael Deats - W.H.O.
Adam Harris - Quintiles IMS
Prof Trevor Jones - King's College London
Kyle Leeman - Pfizer
Kenneth Leiper - Benson Associates
Dr Per Troein - Quintiles IMS
Dr Steve Wicks - Medway Centre for Pharmaceutical Sciences



DETAILS

Thursday 11th May 2017
The role of MS in impurity profiling
Royal Society of Chemistry, London
In association with the British Mass Spectrometry Society.

Impurities provide no benefit to patients; however, it is pragmatically accepted that complex, multi-stage pharmaceuticals cannot be manufactured without drug substance impurities or that drug products cannot be manufactured and stored without degradation products.
This symposium will explore the role of Mass Spectrometry (MS) in the identification and quantification of the various impurities that can be formed.
This symposium should be of interest to development, production, and academic scientists, as well as contract research organisations (CROs).

Speakers:
Dr Claudio Brunelli - Pfizer
Dr Elspeth Gray - MHRA
Dr Sarah James - LGC
Dr Martin Ott - Lhasa
Dr Mark Perkins - Anatune
Dr Andrew Ray - AstraZeneca
Dr Mansoor Saeed - Syngenta
Dr Alec Simpson - GlaxoSmithKline



DETAILS

Thursday 16th March 2017
Assuring data integrity; best practice
Royal Society of Chemistry, London
Data integrity is receiving much attention in the pharmaceutical industry, with several high profile cases where deficiencies have resulted in regulatory action, and the MHRA, FDA, EMA and WHO have all issued guidance documents recently.
This symposium will bring together experts from Health Authorities, pharmaceutical companies, CROs and technology -providers to discuss the approaches being taken to rise to the challenge of increased scrutiny of data management practices.

Speakers:
Steven Brown - Novartis
Dr Adrian Davis - Pfizer Worldwide R&D
Dean Harris - Envigo Ltd
Tracy Moore - MHRA
Dr Gerhard Noelken - Data4Lab Ltd
Paul Smith - Agilent
Mark Stevens - Formpipe Life Science


DETAILS

Thursday 16th March 2017
Annual General Meeting
Royal Society of Chemistry, London
This is a closed meeting for members of JPAG
It is not necessary to register for the symposium to attend the AGM
Starts at 9.30 am

Click here to see the Notice
Click here to see the Minutes of the 2016 AGM


DETAILS

Thursday 9th February 2017
Dissolution testing: current and future considerations
Royal Society of Chemistry, London
Dissolution and disintegration tests for solid oral dosage forms provide insight into the rate of release of the drug into the body. Dissolution has been viewed solely as a quality control tool, but more recently this view has started to change and now there is clear expectation that dissolution must have clinical relevance.
However, the challenge remains: how can a single test be sensitive enough to predict changes that may be of clinical relevance, whilst being robust enough to satisfy the needs of a quality control environment?
This symposium will explore the current state of these techniques from a regulatory, pharmacopoeia, academic and industry perspective, and how emerging bio-relevant dissolution tools can improve our prediction of oral drug behaviour.
This symposium should be attractive to scientists working in research & development, quality control, regulatory, pharmacopoeias and academia. In addition senior managers will benefit from attending.

This symposium is organised in association with the OrBiTo consortium.


Speakers:
Dr Karl Box - Sirius Analytical
Dr Karin Bracht - MHRA
Dr James Butler - GlaxoSmithKline
Dr David Elder - JPAG/Consultant
Dr Edmund Kostewicz - Frankfurt University
Dr James Mann - AstraZeneca
Steve Young - MHRA



DETAILS

Thursday 1st December 2016
Regulatory Hot Topics II
Royal Society of Chemistry, London
This one-day symposium will address issues and challenges associated with the implementation of new and emerging guidelines.
It will provide the opportunity for dialogue and discussion through an effective forum to understand, interpret and translate into day-to-day practice on topics including: ICH Q3D; ICH Q12; continuous manufacture; excipient GMP; allowable flexibility in analytical methods; development and filing of a breakthrough status medicine; microbiological quality of non-sterile dosage forms (USP 1111 and 1115)

Speakers:
Dr Gurjit Bajwa - GlaxoSmithKline
Paul Butterworth - AstraZeneca
Dr Graham Cook - Pfizer
Dr David Elder - JPAG/Consultant
Ewan Norton - MHRA
Dr Stephen Smith - AstraZeneca
Dr Andrew Teasdale - AstraZeneca



DETAILS

Thursday 13th October 2016
Good Distribution Practice: solving implementation and quality issues
Royal Society of Chemistry, London
In a globalised healthcare ecosystem, supply chains become more complex, with an increased potential for quality issue to arises. So, it is critically important to understand Good Distribution Practices (GDP) and the requirements for shared responsibilities throughout the entire supply chain.
This symposium will examine the regulatory requirements of GDP, provide an understanding of the issues and demonstrate how common problem can be overcome.

Speakers:
Julia Claus - Pfizer
Afshin Hosseiny - Tabriz Consulting
Christopher Jones - AstraZeneca
Philip Neale - MHRA
Paul O'Connor - Almac Group
Fiona Routley - AstraZeneca
Emma Thomson - Mawdsleys Clinical Services
Dr Manuel Zahn - 3R Pharma Consulting GmbH



DETAILS

Thursday 23rd June 2016
Practical implementation of ICH Q3D; challenges and solutions
Royal Society of Chemistry, London
This symposium will critically examine the practical challenges associated with effective implementation of ICH Q3D

Speakers:
Dr John Kauffman, FDA
Sven-Erik Hillver, Swedish MPA
Dr Andrew Teasdale, AstraZeneca
Dr Laurence Harris, Pfizer
Samuel Powell, Pfizer
Rob Sharp, GSK
Kevin Hughes, Colorcon


DETAILS

Thursday 12th May 2016
Sterility assurance best practice for aseptically manufactured products
Royal Society of Chemistry, London
The purpose of the meeting is to deliver a best practice forum of like-minded professionals engaged in the manufacture of aseptic pharmaceutical products. JPAG have assembled a strong line up of opinion leaders and experts from the UK regulator, the MHRA, industry and the NHS in the field of aseptic manufacture and microbiological monitoring and testing to provide an excellent opportunity for networking and bench marking for delegates.

The meeting will also play host to equipment providers to show the current state of the art in aseptic manufacturing and testing equipment.

Speakers:
James Drinkwater - Pharmaceutical and Healthcare Sciences Society
Dawn Hiles - Newcastle Cellular Therapies Facility, International Centre for Life
Andrew Hopkins - Expert GMDP Inspector, MHRA
Dr Aileen Hume - AMRI
Yan Hunter-Blair - Newcastle upon Tyne NHS Foundation Trust
Dr Paul Newby - GlaxoSmithKline
Dr Tim Sandle - Bio Products Laboratory



DETAILS

Thursday 17th March 2016
The use of in silico modelling in drug development
Royal Society of Chemistry, London
This symposium is held in association with the Academy of Pharmaceutical Sciences (APS)
This major symposium will provide essential information for all those involved in:
• Formulating medicinal products
• Developing manufacturing processes
• Problem solving and root cause analysis
• Quality control

This symposium is held in association with the Academy of Pharmaceutical Sciences (APS)

Speakers:
Susan Cole - MHRA
Dr Darren Green - GlaxoSmithKline
Dr David Palmer - University of Strathclyde
Dr Kendal Pitt - GlaxoSmithKline
Dr Andrew Teasdale - AstraZeneca
Dr Helen Williams - AstraZeneca
Dr Richard Williams - Lhasa



DETAILS

Thursday 17th March 2016
JPAG Annual General Meeting
Royal Society of Chemistry, London. Science Room
Starts at 9.30 a.m.
The AGM is open to all members of JPAG. It is not necessary to register for the symposium to attend the AGM.


DETAILS

Thursday 4th February 2016
Solving problems with spectral imaging
Royal Society of Chemistry, London
This symposium is held jointly with the Academy of Pharmaceutical Sciences (APS)
Hyperspectral spectral imaging brings great advantages to pharmaceutical analysis by combining the best in spectroscopy and imaging. It solves many problems in analysing solid dosage forms: particle size, shape and distribution; moisture content and location, identification and quantification of individual constituents including polymorphic forms; content uniformity; and assessment of homogeneity

Speakers:
Johannes Khinast - Graz University of Technology
Stephanie Brookes - AstraZeneca
Gerard Byrne - Merck
Sergei Kazarian - Imperial College London
Martin Kuentz - Basel University
Daniel Markl - Graz University of Technology
Christina Pattoni - Pfizer
Dr Sheng Qi - University of East Anglia



DETAILS

Thursday 10th December 2015
Maximising productivity in pharmaceutical QC and stability testing
Royal Society of Chemistry, London
The pressure to increase productivity in the pharmaceutical industry, whilst maintaining compliance and reducing costs, is relentless. This meeting will examine the role of technologies and continuous improvement techniques in optimising throughput, cycle times and allocation of resources in QC and stability testing laboratories, using expert perspectives and case studies from industry, regulatory agencies and partner organisations.

Speakers:
Joanne Hay - MSD
Lesley Graham - MHRA
Andy Rice - GlaxoSmithKline
Susan Smith - AstraZeneca
Roman Szucs - Pfizer
John Trigg - Phasefour-informatics
Bill Young - GlaxoSmithKline



DETAILS

Thursday 8th October 2015
What's new in the approval and conduct of clinical trials in Europe?
Royal Society of Chemistry, London
The implementation of the EU Clinical Trials Directive in May 2004 resulted in significant changes in the approval process and conduct of clinical trials in the EU.
This symposium will describe the changes that are to be introduced by the Regulation, how and when these changes will be implemented, and how this is likely to impact on the attractiveness of the EU for conducting clinical research.

Speakers:
Anne Black - Newcastle upon Tyne Hospital
Dr Graham McNaughton - MHRA
Dr Martin O'Kane - MHRA
Michelle Rowson - MHRA
Dr Peter Scholes - Quotient Clinical
Dave White - AstraZeneca



DETAILS

Thursday 25th June 2015
Challenges in current GMP
Royal Society of Chemistry, London
This programme will focus on current key aspects of GMP, including the evolution of cGMPs since the publication of ICH Q7 in 2000, the potential impact of the ICH Implementation Group and their development of Q&As relating to ICH Q7, and the implications of the EMA Guidelines on shared facilities and exposure limits.


DETAILS

Thursday 14th May 2015
Antibody drug conjugates: analytical efforts and expectations
Royal Society of Chemistry, London
Antibody drug conjugates (ADCs) are an exciting and challenging new area of research and are becoming ever more popular across the industry with more than 50 ADCs reported in the clinic. The targeted nature of the molecules makes them extremely suitable for delivering toxic molecules to the target.
Members of the Drug Metabolism Discussion Group can register at the members rate.


DETAILS

Thursday 19th March 2015
Combating counterfeit medicines: the solutions
Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA
Sub-standard and counterfeit medicines are a great threat to patient health and safety. They may cause death due to the lack of active drug, as found in some vaccines and antibiotics, or because of the presence of a toxic material, such as the substitution of diethylene glycol for glycerol.


DETAILS

Thursday 19th March 2015
Annual General Meeting
Royal Society of Chemistry, London
Starts at 9.30 a.m.
The AGM is open to all members of JPAG. It is not necessary to register for the symposium to attend the AGM.

Thursday 5th February 2015
Quality Risk Management: a pragmatic approach
GlaxoSmithKline, Ware
An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation (ICH Q9).
Scientific approaches are used to estimate the likelihood of any given risk.
This symposium will look at the assessment of risk from an academic, regulatory and industrial perspective and will cover method development, specification setting, chemical purging and genotoxin risk assessment (GRA) using in silico methodologies.


DETAILS

Thursday 11th December 2014
Stability challenges Part II: Assuring the stability of medicines from manufacture to clinical use
Royal Society of Chemistry, London
This symposium examines best practice during the distribution and storage of medicines, to ensure correct storage conditions are maintained and to ensure the quality of the medicine is maintained during use in the clinic or by the patient. The generation of data to support temperature excursions and to demonstrate in-use stability will be explored.


DETAILS

Thursday 3rd July 2014
Assuring the quality of medicines
Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA
The quality of the drug substance and the drug product is critical to ensure the safety and efficacy of medicines. If you have any role in ensuring the quality of medicines, do you have all the tools you need to resolve every-day quality issues?
Qualified Persons (QPs) have a critical role in releasing batches of pharmaceutical products. An understanding of the supply chain and manufacturing challenges is an essential component to the conduct of this role. This symposium takes a strategic look at solving everyday quality issues and the changing role of QPs.


DETAILS

Thursday 15th May 2014
Combating counterfeit medicines: a major and growing challenge to patient safety. Going global
Royal Society of Chemistry, London
Counterfeit medicines - or more appropriately - fake medicines pose great dangers to society. Regrettably, fake medicines are not a new phenomenon. What is new, however, is the recent global escalation of both counterfeit prescriptions and consumer healthcare products.
This symposium provides a current and strategic overview of how industry and regulatory authorities in Europe and the US are addressing the rapidly growing counterfeiting challenge.
This symposium is run in partnership with the Royal Pharmaceutical Society. Members of the Royal Pharmaceutical Society can register at the Members Rate.


DETAILS

Thursday 20th March 2014
Pharmaceutical equivalence, therapeutic equivalence and the role of analytical science
Royal Society of Chemistry, London
The assumption that pharmaceutical equivalence predicts therapeutic equivalence is becoming increasingly contested. The greater complexity of medicinal products and their global sourcing .challenge this belief. Have you been following this important discussion? Do you know and understand what important developments in the scientific and regulatory frameworks are taking place? Are you aware of the implications for the safe use of medicines?
Members of TOPRA can register at the members rate for this event


DETAILS

Thursday 20th March 2014
Annual General Meeting of JPAG
Royal Society of Chemistry, London
The 44th Annual General Meeting of the Group will be held before the Group symposium and will commence at 9.30 a.m.
Please note that you are able to attend the AGM (only) without registering for the symposium.
This meeting is open to members of JPAG only.


DETAILS

Thursday 6th February 2014
Developments in analysis of orally inhaled and nasal drug products
Royal Society of Chemistry, London
This symposium will provide delegates working in the analysis, development or regulation of orally inhaled and nasal drug products with an update on recent developments in the field.


DETAILS

Wednesday 11th December 2013
JPAG symposium: Dissolution of inhaled products: in vitro developments, in vivo relevance and the potential impact on regulatory thinking
Edinburgh International Conference Centre
JPAG half-day symposium in association with the Drug Delivery to the Lungs 24 annual conference organised by The Aerosol Society.
The panel of speakers;: Sau Lee, U.S FDA; Sabine May, PharmBioTec, Sarbrucken, Germany; Rob Price, University of Bath; and Robyn Sadler, GSK


DETAILS

Thursday 10th October 2013
ICH Q3D (Metals Guidelines): Opportunities and challenges
Royal Society of Chemistry, London
New regulations are coming! So, what do you know about ICH Q3D, and what you require to do to ensure you have appropriate control over metals in your products?
Are you confused about why the USP is implementing new general chapters on metals (<232> and <233>) next year that are not fully aligned with either Ph. Eur., or (potentially) Q3D? Are you concerned about your lack of awareness of ICH Q3D?
What do the other pharmacopoeias plan to do? What are the regulators views? What are industrys views?
This symposium will provide you with the opportunity to network with experts, and fellow workers trying to assess the complexity and resource burden that this guidance may bring.


DETAILS

Thursday 4th July 2013
Meeting stability challenges
Royal Society of Chemistry, London
Are you are involved in any aspects of design, implementation or interpretation of stability studies? If so, this one-day symposium will bring you up to speed with current best practice, with presentations from experts in the regulatory and industrial environment, to help you to meet the challenges of your work.


DETAILS

Thursday 16th May 2013
New approaches in bioanalysis and analytical toxicology
Royal Society of Chemistry, London
Increasingly asked to provide ever-more analytical data?
Are the samples becoming smaller, more complex and more challenging to deal with?
Our experts will reveal their novel solutions to answer these challenges with radical new approaches to make the impossible possible.
Held in partnership with the Drug Metabolism Discussion Group.


DETAILS

Thursday 21st March 2013
Progress and challenges in pharmaceutical harmonisation
Royal Society of Chemistry, London
Aware of the latest harmonised CMC guidelines? Not sure how to implement them successfully?
From control of impurities to Quality by Design, let our expert speakers update you on the latest CMC developments and issues for international registration.
Come and share your questions and experiences with our speaker panel and fellow pharmaceutical professionals in this great networking opportunity.
If you develop or register new chemical entities, register now - places are limited.


DETAILS

Thursday 21st March 2013
Annual General Meeting of JPAG
Royal Society of Chemistry, London
The 43rd Annual General Meeting of the Group will be held before the Group symposium and will commence at 9.30 a.m.
Please note that you are able to attend the AGM (only) without registering for the symposium.


DETAILS

Thursday 7th February 2013
Assuring the quality of medicines
Royal Society of Chemistry, London
Do you deal with issues on the quality of medicines?
If so, you will want to attend this major symposium which takes a strategic look at resolving day-to-day issues on the quality of medicines.
The programme addresses the role of human error and how to minimise its effects, the security of the supply chain for APIs, the changing role of Qualified Persons and others working in quality control, and the MHRA Surveillance Programme.
Completing a line-up of experts from industry and the regulatory agency will be a panel from the FDA who will examine the transition from validation of batches to the verification of continuous processes.
If you are a QP, or your work relates to any aspect of medicine quality, this is a "must-attend" event.


DETAILS

Thursday 17th May 2012
Advances in Raman spectroscopy in pharmaceutical analysis
Royal Society of Chemistry, London
This major symposium was oganised jointly by the Federation of Analytical Chemistry and Spectroscopy Societies (FACSS), the Joint Pharmaceutical Analysis Group (JPAG), the Royal Society of Chemistry Molecular Spectroscopy Group (MSG) and the Infrared & Raman Discussion Group (IRDG)
Raman spectroscopy has found favour in pharmaceutical analysis because it is non-destructive, requires minimal sample preparation and gives clear spectra for identification. The programme demonstrated a breadth of successful Raman applications spanning the R&D field, active pharmaceutical ingredients (API) development, scale-up and manufacturing, as well as drug product formulation development, characterisation and product assay.
The Duncan Bryant Prize for the best poster, awarded by the Royal Society of Chemistry Molecular Spectroscopy Group, was won by Miss Rajni Miglani of Strathclyde University.
The Joint Pharmaceutical Analysis Group acknowledges with thanks the sponsorship of this symposium by the following companies: Clairet Scientific, Horiba, BaySpec, Lambda Photometrics and Cobalt Light.


DETAILS

Thursday 22nd March 2012
Advances in pharmaceutical analysis
Royal Society of Chemistry, London
Analytical technologies must evolve continuously to characterise increasingly complex pharmaceutical products and processes in an efficient and effective way.

This one-day symposium will examine developments in analytical techniques and practices to address current scientific and regulatory challenges in pharmaceutical development and quality control.


DETAILS

Thursday 22nd March 2012
JPAG Annual General Meeting
Royal Society of Chemistry, London
The 42nd Annual General Meeting of the Group will be held on Thursday 22nd March 2012 at the Royal Society of Chemistry, Burlington House, Piccadilly, London.
The AGM will commence at 9.30am, before the JPAG Conference Advances in Pharmaceutical Analysis


DETAILS

Thursday 8th December 2011
Predictive tools in the development of solid oral dosage forms
Predictive modelling approaches are demonstrating increasing value throughout the product development cycle, from the prediction of physiochemical properties
of potential drug candidates in discovery, through the prediction of product characteristics and performance during clinical development, to the understanding of powder behaviour during large-scale manufacture.


DETAILS

Wednesday 31st August 2011
Measurement for the control of continuous processes
This seminar examined how innovative applications of measurement sciences are
pivotal to the implementation of the transition from batch to continuous processing, to deliver the full benefit of these changes as a key aspect of The Science of Medicines.


DETAILS

Thursday 7th July 2011
Best practice for outsourcing of analytical support and use of contract laboratories
Pharmaceutical and biotechnology companies now outsource at almost every stage of the product life cycle. This trend is supporting a thriving services sector by outsourcing a broad range of skills and technologies required for drug discovery, development and manufacturing. A substantial part of the outsourcing involves pharmaceutical analysis.


DETAILS

Thursday 16th June 2011
Analytical methods to combat the counterfeiting of medicines
Sub-standard and counterfeit medicines are a great threat to public health. They may cause death due to the absence of active drug, as found in some vaccines and antibiotics, or because of the presence of a toxic material, such as the substitution of diethylene glycol for glycerol.

Counterfeit medicines are estimated to constitute 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 2011.


DETAILS

Thursday 24th March 2011
Counterfeit medicines: the regulatory and industrial challenges
Counterfeit medicines or -- more appropriately -- fake medicines are not a new phenomenon but continue to be a very dangerous threat to life and health. What is new, however, is the recent global escalation of counterfeit prescription medicines and healthcare products.


DETAILS

Tuesday 15th March 2011
Analytical challenges in the qualification and validation of pharmacodynamic biomarkers
Biomarkers are surrogates for the measurement of pharmacodynamic responses to drugs and vaccines.

At this symposium a panel of speakers presented current concepts in the qualification and validation of biomarker assays, including discussions on standard ELISA formats and the application of other platform technologies, including Flow Cytometry, ELISpot, Q-PCR, Gyros, LC/MS and multiplex platforms such as Luminex and Meso Scale Discovery (MSD).

The concept of a fit-for-purpose method qualification and validation, selection of reference material, QCs, and relevant acceptance criteria was examined. The various biomarker approaches including clinical diagnostics, immunogenicity, companion diagnostics and the use of commercial human kits for pre-clinical applications were reviewed.

Thursday 3rd February 2011
Measurement challenges in the analysis of topical products
The delivery of medicinal products to the skin or mucous membranes presents a number of challenges during product development and quality control of commercial products. This symposium addressed measurement challenges that arise with products for topical administration, focussing on analytical techniques used to characterise and control topical products, including creams, ointments, gels and products for inhalation.

The programme included contributions from key industrial, academic and regulatory speakers on fundamental techniques used to analyse topical products, such as rheology, thermal analysis, microscopy and gamma-scintigraphy.






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