Pharmaceutical and Life Sciences

2005

PHARMACOVIGILANCE
Introductory course designed specifically for personnel involved in Clinical Trials, Clinical Studies and Post-Marketing
10th February
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Conference No A2-1405
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CHANGES IN THE NHS – IMPLICATIONS FOR THE PHARMACEUTICAL INDUSTRY
10 February
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The expert speaker panel at this meeting will explore the enormous change taking place in the NHS - What are the actual implications here for a major supplier to the NHS – the Pharmaceutical Industry –and could there be more opportunities than threats ? Should the Industry continue to be thinking of different ways of working with the NHS and seeking new kinds of partnership arrangements? This meeting will address some of these key issues
Conference No A2-4205
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PHARMACOVIGILANCE: COMPLIANCE & QUALITY ASSURANCE
11 February
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Conference No A2-1305
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CONTROLLING EXCIPIENTS:
14 February
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Pharmaceutical and Regulatory Matters. Licensing - Pharmacopoeias - Good Manufacturing Practices - Innovative Application of Testing Methods
Conference No A2-6105
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CTD: CLINICAL OVERVIEW AND CLINICAL SUMMARY
16 February
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Latest guidance on how to prepare the Clinical Overview and Summary in accordance with regulatory expectations.
Conference No A2-1205
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HOW TO PREPARE CLINICAL SOPs
18 February
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This SOP course has been specifically designed to help you develop the skills to write, review and manage SOPs and in particular to be able to comply with the new Clinical Trial Directive. SOPs play a vital and practical role in ensuring compliance with this important Directive. It is essential therefore to have a number of new SOPs written, and for several existing SOPs to be updated, otherwise this is likely to result in major findings by regulatory inspectors.
Conference No A2-4305
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Design and Conduct of
CLINICAL TRIALS IN RESPIRATORY MEDICINE
20/21 February
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This meeting will present expert detailed overviews of key aspects of the design and conduct of clinical trials with respiratory disorders including asthma, COPD, allergic rhinitis and paediatric conditions.
Conference No A2-1105
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ASSAYS FOR CHARACTERISING CLINICAL BIOLOGICAL MACROMOLECULES
Technical and Regulatory Challenges
23 February
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This seminar will address the role and significance of biological assays, and their application during the development, routine manufacture and preclinical and clinical testing of this product class. The nature and applications of bioassays and complementary physicochemical analysis of biological macromolecules will be set in the context of generating quality, safety and efficacy data for regulatory use in the drug development and approval process.
Conference No A2-8605
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PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLE EAST
24/25 February
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The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in the Middle East, including Turkey and Israel, focusing on the practical aspects to assist regulatory activities in the region and will include opportunities for interactive discussions/break-out sessions.
Conference No A2-6005
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THE PHARMA MINI MBA
28 February - 2 March
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This intensive three day course covers the core areas of an MBA and applies these skills to the pharmaceutical industry – using industry case studies and your own issues. This ‘Mini MBA’ is especially designed to build your management skills for the future and to enable you to more effective and efficient. This three day interactive workshop will work through live issues impacting on the Industry and on participants directly. Key benefits are individual learning, attitude and behaviour shift and diagnosis of current business and organisational issues.
Conference No A2-4005
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PHARMACEUTICAL REGULATORY AFFAIRS IN ASIA
3/4 March
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Day I: China, Hong Kong, Macau, ASEAN: Brunei, Indonesia, Singapore and Thailand
Day II: Korea, Taiwan, ASEAN: Cambodia, Malaysia, Laos, Philippines and Vietnam
The aim of this meeting is to provide an understanding of the key areas of regulatory affairs in Asia, focusing on the practical aspects to assist regulatory activities in this region and will include the latest updates and opportunities for interactive discussions.
Conference No A3-6205
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IMPURITIES IMPURITIES
Chemical, Pharmaceutical, Pharmacopoeial, Biological, Microbiological, Licensing, GMP and other Regulatory Matters
3/4 March - IN BARCELONA
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Conference No A3-6305
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MONITORING TO GCP & THE EU CLINICAL TRIAL DIRECTIVE
7/8 March
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Monitoring clinical trials to comply with GCP and the EU Clinical Trial Directive is vitally important to meet regulatory requirements and company SOPs. This interactive course will cover all the key aspects of monitoring a clinical trial, including This will include planning and preparation for setting up clinical trials, understanding the responsibilities at both the study site and the sponsor site, and how to carry out the crucial study site visits
Conference No A3-4205
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SUCCESSFUL MEDICAL WRITING
9-11 March
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This intensive and interactive course combines lectures with practical exercises to provide a thorough introduction to the basics of medical writing that goes beyond the usual ‘overview’ courses. It will provide in-depth training in general writing and data presentation skills, and specifically in the kind of documents most frequently encountered in clinical research.
Participants will learn both the theoretical and practical aspects of writing for regulatory authorities as well as the sensible use of international guidelines, standards and useful writing tips. Many illustrative examples will be used, drawn from the seminar leaders’ wide experience of the pharmaceutical industry.
Conference No A3-3205
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PHARMACOKINETICS/DYNAMICS: ADVANCED COURSE
10 March
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For some years Scientific literature has discussed building models to aid understanding of pharmacokinetic and pharmacodynamic processes that underlie drug action. However, within the drug development environment, it is only relatively recently that the prospective application of exposure response relationship characterisation has become more widespread.Climate changes with the Pharmaceutical Industry and Regulatory Agencies are driving the need for a more comprehensive adoption of these approaches.As the product of drug development is "knowledge", and its appropriate utilisation is essential in permitting the pharmaceutical industry to meet future challenges, modelling, simulation and CATD can provide an important technical solution to "knowledge management" strategies.
Conference No A3-1205
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BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST
10/11 March    
The purpose of this seminar is to provide non-biotechnologists with the basic theory to understand the principles, techniques and potentials of biotechnology. Biotechnology is the use of biological processes to provide useful products, services and environmental management.Biotechnology combines disciplines such as molecular biology, biochemistry, chemistry microbiology, chemical engineering and computing. This rapidly advancing science offers new and exciting opportunities to mankind, especially in the fight against disease.
Conference No M3-6405
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CRITICAL SUCCESS FACTORS FOR POM TO P SWITCHING
14 March
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The reclassification of prescription medicines from POM to P can benefit the pharmaceutical industry, by giving the potential to extend the commercial life of products whose patents have expired, and to allow advertising to the public of the deregulated products, so long as the indication is suitable. However, in the P market the payback period is significantly longer and the challenge of delivering acceptable and profitable growth is much greater. This seminar will examine the opportunities and issues around successful switching. Recent switches will be examined to identify what went well and what could be improved upon.
Conference No A3-4305
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REGULATORY ASPECTS OF HERBAL MEDICINE
14 March
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The regulatory landscape for Herbal Medicinal Products is at the point of change. The European Commission has issued a new Directive to regulate the sale and supply of Traditional Herbal Medicinal Products. The Directive amends Directive 2081/83EC, which regulates the sale and supply of all medicinal substances and products. The Directive will have long term and far reaching effects upon the market for Herbal Medicinal Products throughout the European Community. This seminar is designed to address many of the issues involved, including Pharmaceutical GMP, Quality Standards, Safety and the qualifying criteria for efficacy. Estimates of approximate timetables for implementation will also be discussed.
Conference No A3-4405
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MICROBIOLOGY FOR THE NON-MICROBIOLOGIST: A Guide to Survival
14/15 March IN AMSTERDAM, THE NETHERLANDS
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Microbiological issues play a key part in the production and control of manufactured items. The object of this seminar is to provide non-microbiologists with an overview of the basic theory and practical relevance of microbiology as it relates to the working environment.
Conference No M3-6005
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ADR MONITORING AND SAFETY SURVEILLANCE STRATEGIES IN EUROPE AND THE USA
15/16 March
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This year's conference will concentrate on the challenges and opportunities of utilising observational databases, both in Europe and the US. Methods of communication of drug safety information both electronically and operationally, prescription event monitoring, medical dictionaries, postmarketing safety studies and signal generation issues will be reviewed as well as methods of managing global pharmaceutical changes. European strategies of risk management and issues during development and the product life cycle will be discussed and also the role of the qualified person.
Conference No A3-1005
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NICE & THE PHARMACEUTICAL INDUSTRY
In association with the National Institute for Clinical Excellence
17 March
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The National Institute of Clinical Excellence (NICE) was set up in 1999 as a Special Health Authority, with the objective of improving the quality of care NHS professionals provide their patients. Because NICE is required to consider both clinical issues as well as cost effectiveness, in formulating its advice, its role and guidance is sometimes controversial. This meeting will bring together experts from NICE itself, as well as Industry representatives, to assess the importance of the Institute and clarify its current and future roles. This includes the implications of NICE taking on the functions of the Health Development Agency The appraisal process and clinical guidelines process will both be discussed, as well as the key issue of the implementation of NICE guidance.
Conference No A3-4005
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BORDERLINES BETWEEN COSMETICS AND DRUGS
18 March
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There is increasing interest in the medicinal use of cosmetics. The reasons for this include the trends to self medication and pharmacy treatments plus the increasing numbers of individuals who present with their skin related complaints. In addition, there is a growing recognition of a pharmacological activity and clinical usefulness of many agents previously classified as cosmetics. This important meeting will address the main issues surrounding the shifting borderline between cosmetics and drugs, including the latest statutory procedures and how Industry can work within the Regulations
Conference No A3-4105
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THE FDA GENERIC DRUG APPROVAL PROCESS
4 April
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This seminar will highlight new changes to the US generic drug regulations and provide an overview of the submission of documents to the FDA for approval of generic drugs. Participants will gain a better understanding of the US generic drug approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information and obtain product approval.
Conference No A4-4305
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VARIATIONS TO MARKETING AUTHORISATIONS
4 April
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An introduction to the EC system for variations with practical advice on the preparation and submission of variation applications using the various European procedures. Including: Regulations of the European Commission and procedures in practice; pharmaceutical variations; Clinical Variations
Conference No A4-1205
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ABRIDGED PRODUCT LICENCE APPLICATIONS
5 April
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An intensive course examining the current requirements for those with a basic knowledge of the application procedure
Conference No A4-1305
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FDA APPROVAL PROCESS FOR BIOLOGICAL PRODUCTS
7/8 April
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This seminar will provide an overview of the FDA system for approval of biological products. Participants will receive a foundation of knowledge about the biological approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided as well as information on submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval.
Conference No B4-8505
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GCP COURSE - FOUNDATION LEVEL
7/8 April
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With the implementation of the Clinical Trial Directive it is now essential to show that both the sponsor staff and investigator site staff can demonstrate a good knowledge of GCP and the Clinical Trial Directive. Inspectors from the regulatory authorities will ask for evidence that all study staff have received GCP training and it is also essential that investigator site staff can demonstrate competence in GCP both to inspectors and as evidence of suitability of investigator staff to the Ethics Committee review. This course will take you through the key areas of the GCP and the Clinical Trial Directive with an optional validated Certification examination to assess your knowledge of GCP standards.
Conference No A4-4105
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A discounted rate is available if both courses booked together
PHARMACOKINETICS: WORKSHOP FOR BEGINNERS
12 April
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This one-day course is intended to provide a basic knowledge and understanding of the main principles and concepts of Pharmacokinetics and Pharmacodynamics, as opposed to an appreciation of their place and utility in drug development. The day will provide a theoretical overview and will be a useful grounding for the following intermediate course. There willbe equations, but they will be small ones!
Conference No A4-1005
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PHARMACOKINETICS: INTERMEDIATE COURSE
13/14 April
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Pharmacokinetics and metabolism are now accepted as key disciplines in drug development, providing an insight into differences in drug action within and between species. Unfortunately for many people it is also one of the more complex to understand and to put into practice, particularly with the new approaches such as in-vivo metabolism, genetic polymorphism, interaction studies kinetic-dynamic modelling, bioavailability, population kinetics, biotechnology etc. The lecturers will provide information on the use and benefits of pharmacokinetics in drug development and how it affects drug discovery.
Conference No A4-1105
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STABILITY TESTING
Current Issues - Approaches - Outcomes
14/15 April
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This conference will survey and probe numerous issues concerning drug substance and drug product stability. The relevance of ICH and other guidelines will be demonstrated and delegates will learn how to generate re-test dates for drug substances and shelf lives for drug products.
Conference No A4-6205
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PATENTABILITY PROBLEMS IN MEDICAL TECHNOLOGY
15 April
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The patenting of medical methods (methods of treatment by surgery, therapy or diagnostic methods) has always been a controversial topic under all patent laws, and subject to varying jurisprudence, and the question arises as to the degree to which there are specific aspects of patent law relating to this significant branch of technology. This seminar will attempt to show how the provisions of the EPC are handled in practice by the EPO.
Conference No H4-3205
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BRAILLE FOR PHARMACEUTICAL PACKAGING
19/20 April
Conference No M4-6105
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GMP FOR IMPs: GOOD MANUFACTURING PRACTICE FOR INVESTIGATIONAL MEDICINAL PRODUCTS
GCP DIRECTIVE          GMP DIRECTIVE         ANNEX 13
21 April
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Ensure that you are in compliance: Are you aware that Clinical Research Personnel should be trained to GMP related to IMP?
Conference No A4-6605
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CLINICAL TRIALS: AUDIT AND INSPECTION
25 April
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This course will enable you to learn how to prepare to be audited and inspected in the new regulatory environment. It will be equally useful to those wanting to understand how to carry out an audit. You will learn what to expect from an audit and regulatory inspection, the different types of audit, review audit and inspection findings, how to manage post audit procedures such as responding to audit and inspection reports. You will also gain an insight from an European Community Inspectorate.
Conference No A4-4005
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'SMART' PHARMA PROCESSES
28/29 April
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Innovative approaches to ensuring that key objectives are met are being investigated at all levels in the Pharma Industry. Process re-engineering is now critically important to leading pharmaceutical organisations - with fewer NCE reaching the market place, costs of drug development rising, increasing regulatory requirements, and government pressures on pricing to name but a few. Pharma is having to focus on extending its product drug life-cycles, on other value creating opportunities, and process re-engineering will help ensure financial growth and stay ahead of the competition. This workshop will help you to deliver your department’s, team’s and individual’s goals more effectively by becoming significantly smarter about how you do things within your department processes.
Conference No A4-4205
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EU CHEMISTRY AND PHARMACY REGULATORY PROCEDURES AND REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS
12/13 May in CORK, IRELAND
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The Pharmaceutical Dossier
(CTD ‘Quality’ Modules 2.3 and 3)
Conference No A5-6005
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TOPICALS: CREAMS, LIQUIDS, OINTMENTS AND PATCHES
Pharmaceutical and Regulatory Matters
17 May
Conference No A5-6105
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INTRODUCTORY OVERVIEW OF THE PHARMACEUTICAL INDUSTRY
23 May
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For all staff working throughout the Pharmaceutical Industry – especially non-technical staff, new to an area/department, those new to the industry and those wanting to understand what colleagues in other departments are trying to achieve and why.
Conference No P5-3305
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EU CLINICAL TRIAL DIRECTIVE - ONE YEAR ON
24 May
Conference No A5-4205
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EUROPEAN REGULATORY PROCEDURES AND STANDARDS
This course aims to fit in all the regulatory essentials – if you can only spare 3 days out of the office, then this is the course for you.
25-27 May
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The course is designed to offer both an introduction to EU regulatory topics and an update on current issues and recent changes.
Conference No A5-1005
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THE ROLE OF THE QUALIFIED PERSON IN PHARMACOVIGILANCE
26 May
The brochure for this meeting will be available shortly
This seminar will offer guidance from members of industry and the regulators as to the requirements laid down, and examples given of role models used in different sized companies. Special problems will be discussed, with practical advice as to fuulfilling the legal requirements.
Conference No A5-1105
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QUALITY (CMC) CONSIDERATIONS FOR JAPAN
14 June
This new seminar will include the impact of the PAL revisions to CMC documentation, latest MHLW information on the new system for Licensing and an overview of potential review issues and frequently asked questions on the quality aspects of a JNDA.
Conference No A6-6005
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BASIC COURSE ON PHARMACOVIGILANCE
15-17 June
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmaocvigilance in Europe and the USA.
Conference No A6-1105
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PHARMACEUTICAL APPLICATIONS IN THE EU
7/8 July
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The seminar will give the attendees an understanding of the requirements and registration procedures in the EU. The workshop will help the participants to consolidate their understanding of the complexity of the process.
Conference No A7-6005
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CHEMICAL REFERENCE STANDARDS
July date to be confirmed
Conference No M7-6305
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EU CHEMISTRY AND PHARMACY REGULATORY PROCEDURES AND REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS
26/27 September in BUDAPEST, HUNGARY
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The Pharmaceutical Dossier
(CTD ‘Quality’ Modules 2.3 and 3)
Conference No A9-6105
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BIOTECHNOLOGY FOR THE NON-BIOTECHNOLOGIST
29/30 September
The purpose of this seminar is to provide non-biotechnologists with the basic theory to understand the principles, techniques and potentials of biotechnology. Biotechnology is the use of biological processes to provide useful products, services and environmental management. Biotechnology combines disciplines such as molecular biology, biochemistry, chemistry microbiology, chemical engineering and computing. This rapidly advancing science offers new and exciting opportunities to mankind, especially in the fight against disease.
Conference No M9-6005
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STABILITY TESTING
Current Issues - Approaches - Outcomes
6/7 October
This conference will survey and probe numerous issues concerning drug substance and drug product stability. The relevance of ICH and other guidelines will be demonstrated and delegates will learn how to generate re-test dates for drug substances and shelf lives for drug products.
Conference No A10-6105
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EU CHEMISTRY AND PHARMACY REGULATORY PROCEDURES AND REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS
17/18 November in BARCELONA, SPAIN
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The Pharmaceutical Dossier
(CTD ‘Quality’ Modules 2.3 and 3)
Conference No A11-6005
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If there are any other topics you would like us to cover please contact either
Zena Singer   (Pharmaceutical/Respiratory)
Ellen Walker  (GxP)
Andrea James (Medical Devices)
Sarah Spanswick  (Managerial Strategies,  Pricing & Reimbursement, Clinical Trials)

Tel: +44(0)1483 570099