EUROPEAN CONTINUING
EDUCATION COLLEGE

COURSES FOR 2006

CURRENT REQUIREMENTS FOR CHEMISTRY AND PHARMACY SECTIONS OF REGULATORY SUBMISSIONS

A THREE DAY INTENSIVE COURSE PROVIDING AN OVERVIEW OF CURRENT REQUIREMENTS RELATING TO MANUFACTURE AND CONTROL OF PHARMACEUTICALS WITHIN SUBMISSIONS FOR CLINICAL TRIALS AND MARKETING AUTHORISATIONS

6^th, 7^th and 8^th March 2006, Kensington Park Hotel,Kensington, London, U.K.

COURSE BACKGROUND AND OBJECTIVES

This course has been designed to provide an up-to-date and detailed review of the requirements that relate to the chemistry and pharmacy sections of submissions to authorities responsible for the regulation of medicines. Particular features of the course are the hypothetical case histories included in the workshops and the provision of ample opportunities to review and discuss specific problems.

KEY BENEFITS OF ATTENDING

Attendees o­n this course with its incorporated workshop sessions, can expect to gain an enhanced appreciation of:

1.The scientific rationale underlying various regulatory requirements and what

the authorities expect within submissions.

2.The interdependency of the contributory roles of each participatory scientific

discipline in the preparation of an acceptable dossier.

3.Means of maximising the efficiency of timetabling activities and of deploying

resources so as to secure expeditious preparation of the manufacturing and

controls sections of regulatory submissions.

WHO SHOULD ATTEND

Any scientist or manager having responsibility for, or direct involvement in, the generation of data for, and for the incorporation of information in, the chemistry and pharmacy sections of dossiers for submission to medicines regulatory bodies.

The Course should prove of excellent value to pharmacists involved in formulation or in manufacturing, chemists concerned with synthesis and development, analysts, microbiologists, product planners and personnel concerned with standards, stability testing, packaging, product registration and regulatory compliance.

COURSE OUTLINE

INTRODUCTION AND OVERVIEW

Review of the various categories of regulatory submissions and the guidelines published by the major authorities. Harmonisation of requirements. Formats and contents.

THE ROLE OF THE M.H.R.A.

The regulatory strategy and what is expected within submissions.

ANALYTICAL ASPECTS

Including I.C.H. guidelines and method validation

STABILITY CONSIDERATIONS

The requirements pertaining to demonstration that the medicine has acceptable stability.

CONTROL OF THE DRUG SUBSTANCE/IMPURITIES

Development chemistry and control of starting materials; the different classes of impurities; how requirements differ with the differing types; batch analysis.

DEVELOPMENT PHARMACEUTICS

Formulation aspects, manufacturing process and validation.

MICROBIOLOGICAL CONSIDERATIONS

Requirements for different classes of medicines pertaining to microbiological contamination.

PACKS AND PACKAGING MATERIALS

What is required of the pack and the generation of the information expected by the authority; labelling requirements; patient information leaflet.

CONTROL TESTS o­n THE FINISHED PRODUCT

The design of the Finished Product Specification.

COMMON TECHNICAL DOSSIERS

The pharmaceutical expert and the preparation of CTD’s.Preparation of the Expert Report/Quality Overall Summary.

THE PHARMACEUTICAL DOSSIER

A review of the pharmaceutical dossier.

MASTER FILES AND CERTIFICATIONS

An account of the various categories and the circumstances of their applicability. The requirements of format and content.

WORKSHOPS/TUTORIALS

These are an integral part of the course and involve participation in exercises relating to:

· Rational construction of submissions

· Interpretation and application of requirements

· Identification of shortcomings in some hypothetical submissions

· Common Technical Dossiers

LECTURERS

RICHARD O’NEILL LLB, LLM, B.Pharm., Ph.D., M.R.Pharm.S. (Course Director)

Dr O’Neill is Principal Lecturer in Law, Ethics and Pharmaceutics at the School of Pharmacy at the University of Hertfordshire. He has acted as an independent consultant and was, previously, at the School of Pharmacy, University of London. Dr O’Neill has been involved for over 25 years in teaching the science of dosage form design, including stability testing of drugs and formulated products, as well as teaching the law relating to medicines, the practice of pharmacy and professional ethics. From 1980 to 1984, he was Education and Training Pharmacist for the East Anglian Regional Health Authority and between 1991 and 2001 acted as RPSGB Registration Examination Coordinator o­n behalf of the London Pharmaceutical Consortium. He has been involved for a number of years in organising and directing postgraduate continuing education courses for the pharmaceutical and healthcare industries.

MALCOLM DASH B.Pharm

Mr Dash is a Senior Pharmaceutical Assessor at the Medicines and Healthcare Products Regulatory Agency in the U.K..He is responsible for the assessment of Applications both national and mutual recognition, EDMF’s and Certificates of Suitability. He is the UK nominated expert o­n EDQM/PhEur Certification Scheme and has specific expertise in EDMF’s, Certificates of Suitability, Modified Release, etc. He has a very active working involvement with the UK Medicines Inspectorate. Previously Mr Dash has had 13 years industrial experience at GlaxoSmithKline in both a formulation role and clinical trial supplies preparation. Mr Dash is a Member of the Management Committee of JPAG.

STEVEN BOOTH B.Pharm., Ph.D., M.R.Pharm.S., C.Eng., F.I.Chem.E., C.Sci.

Dr Booth is Senior Director of Formulation and Process Design at Merck. Sharp & Dohme. He has responsibilities in formulation and process development and has published widely in the area of powder mechanics and drug delivery.

JOHN GLASBY Ph.D., B.Pharm., B.A. (Law)., M.R.Pharm.S.

Dr Glasby is aConsultant for Kendle International Ltd., a regulatory affairs consultancy and was previously the Managing Director of Kendle International. Until 1989 he worked for Fisons Pharmaceuticals in Development and Regulatory Affairs and later in Regulatory Affairs for Fisons in the U.S.A. He has very extensive experience of regulatory affairs as it affects clinical trials.

JOHN M. MIDGLEY O.B.E., BSc., M.Sc., Ph.D., F.R.Pharm.S., F.R.S.C., C.Chem.

Professor Midgley is Emeritus Professor and Research Professor of Pharmaceutical and Medicinal Chemistry at the University of Strathclyde. Until very recently he was a Member of the Committee o­n the Safety of Medicines, and of its Chemistry, Pharmacy and Standards Sub-Committee (which he Chaired), for twelve years. Currently he serves o­n the External Advisory Panel of the MHRA. He was a Member of the Committee o­n Review of Medicines from 1984 to the end of its remit in 1992 and is currently a Member of the European Panel of Experts o­n Human Medicines (since 1995), the British Pharmacopoeia Commission (since 1984: including Chairmanship of Committee B, Medicinal Chemicals), the U.K. Delegation to the European Pharmacopoeia Commission (since 1998) and is Chairman of the EPC’s Group of Experts 10A (Organic Chemistry, Synthetic Products). He has evaluated over 5,000 Marketing Authorisation Applications and was invested as an Officer of the Most Excellent Order of the British Empire (O.B.E.) for Services to the British Pharmacopoeia and to Regulatory Medicine in 1998. He is a Fellow of the Royal Pharmaceutical Society of Great Britain and of the Royal Society of Chemistry and has published over 150 papers o­n various aspects of pharmaceutical/analytical chemistry, synthetic organic medicinal chemistry and related subjects. Since 1967 he has acted as a Consultant for a large number of pharmaceutical/chemical companies worldwide, particularly in Europe, the USA and Japan.e

PETER TAYLOR MIBiol., Ph.D.

Dr Taylor is Reader in Pharmaceutical Microbiology at the School of Pharmacy, London University. He has very extensive experience in medical microbiology and has worked for numerous pharmaceutical companies. His research interests include novel approaches to the treatment of infectious diseases and site-selective drug delivery.

KATE ARNOT B.Sc., M.Sc., C.Chem., M.R.S.C.

Ms Arnot is Manager, Regulatory CMC at AstraZeneca with responsibilities for providing specialist CMC advice in support of development projects for N.C.E.’s and line extensions with a view to achieving a ‘global development’ and rapid approval for clinical and marketing submissions. Ms Arnot has over 12 years experience of analytical development in the pharmaceutical industry and has been involved with projects at all stages from early exploratory to development for launch. She has had recent experience of preparing drug substance and drug product contributions and responding to regulatory queries o­n the CMC section of a marketing submission for an NCE in 3 major markets (U.S., E.U. and Japan).

MICHAEL PARKER B.Pharm., Ph.D.

Dr Parker is Assocaite Director, Product Development, Pharmaceutical and Analytical R & D at AstraZeneca. He is responsible for the development of oral dosage forms of AstraZeneca’s new products and their associated manufacturing processes. This includes review and approval of all relevant CMC documentation. Previously Dr Parker has had 15 years experience in the design and development of oral and parenteral dosage forms and in the management of pilot scale GMP manufacturing facilities.

ARNOLD STEAD B.Pharm., Ph.D., C.Chem., F.R.S.C., M.R.Pharm.S.

Dr Stead is an independent consultant in pharmaceutical research, development and regulatory affairs. He has worked in the pharmaceutical industry for over 25 years including posts as Scientific Advisor to Hoechst Marion Roussel Ltd., and Head of Development at Roussel Laboratories. During 1996 he was an advisor to the World Health Organisation’s Task Force o­n long acting contraceptives. He has been responsible for the development of a wide range of currently marketed products and is the author or co-author of some 30 publications in the pharmaceutical sciences. His first of many pharmaceutical expert reports was in 1985.

GEORGE JOHNSON B.Sc., M.Sc. Ph.D., C.Chem., F.R.S.C.

Dr Johnson is Associate Director, Analytical R & D, Pharmaceutical Sciences at Pfizer Global Research. He leads a team of 30 analytical staff and UK business lead for LIMs development. In addition to currently leading an analytical group focussed o­n expediting exploratory drug development and product enhancement, Dr Johnson maintains an active interest in the enhanced use of informatics (eg. LIMs and data archiving) and automation to deliver compliance and productivity gains for the business.

ABOUT THE COLLEGE

The European Continuing Education College, is now well established worldwide as the leading provider of up-to-date, pragmatically orientated, relevant short courses for Managers, Scientists, Engineers and Technicians. The College specialises in Courses for the pharmaceutical, biotechnology and healthcare industries. These courses are tailor-made to the requirements of the industry and as a result provide information of tremendous benefit to those who may not necessarily be at the forefront of knowledge in a particular area. Over the years our pharmaceutical courses, under the Direction of Professor Mike Rubinstein, have proved extremely popular and are often heavily oversubscribed. This success is mainly due to the very careful selection of material and lectures for the Courses, to the provision of workshops, clinics, case studies and discussion sessions, to the very extensive course notes provided and to small group participation.

Presenters are very carefully chosen from academia and the industry who are both experts and accomplished teachers and great care is taken to ensure that the Courses are right up-to-date and that there is proper integration of both the theoretical and practical considerations of the subject. All material is reviewed and assessed to make sure it is pertinent and relevant. Demonstrations, Case Studies and Workshops of actual pharmaceutical equipment, processes and methods are general features of most of the College courses. In addition most of our courses include problem solving sessions and recently the College has introduced E.C.E.C. Technical Clinics. Participants o­n our courses can let us know beforehand or bring with them, a particular problem or problems pertinent to the subject area of the course, which they would like advice about. This advice will be given either confidentially or more usually at a special open discussion session during the course, at which other participants can offer their advice and experience as well.

The E.C.E.C.also provides tailor-made ‘in-house’ courses for Pharmaceutical, Biotechnology and Healthcare companies.

If you would like further details of our forthcoming Courses, please ask our Office to put you o­n our mailing list. If you require details of our ‘in house’ course service, please contact our Office for more information.

FEES AND REGISTRATION

The participation fee is £1355.00 (exclusive of VAT). Places are strictly limited and therefore applications will be accepted o­n a first come basis. Under UK law all applications are subject to Value Added Tax (VAT) irrespective of the country of origin of participants. Most VAT registered companies/organisations can reclaim this tax. The fee includes full personal participation, extensive bound course notes, luncheons and light refreshments, o­n all days of the Course.Dinner at night is not included. Cancellations cannot be accepted less than 14 days prior to the start of the Course, but substitutions may be made at any time. The Course language will be English. An approved Certificate of Attendance will be given to each participant at the end of the Course.

TIMING OF THE COURSE

Registration will be at 8.45am o­n Monday 6^th March and the Course will commence promptly at 9.00am. The Course will finish at about 17.00 o­n Wednesday 8th March. The Course will end at about 18.00 o­n each of the first two days.

‘E.C.E.C. TECHNICAL CLINIC’

The College recognises that participants may have a particular problem or problems that they would like advice about. o­n this course participants are invited to send in beforehand (or bring with them) details of their technical problems, which will be considered by the lecturers. A special open discussion session has been timetabled o­n this course at which participants’ problems will be discussed and advice given. At this session other course participants can offer their advice and experiences as well. If you would like advice to be given confidentially, please advise the College beforehand.

ACCOMMODATION

A special room rate of £138.00 (normal rate £190.00) per night single with bathroom, inclusive of breakfast (£172.00 twin/double (normal rate £207.00)), exclusive of VAT, has been negotiated for participants o­n this Course at the superb 4 star luxury Kensington Park Hotel in fashionable Kensington. The Hotel is opposite Kensington Palace and is peacefully situated in De Vere Gardens, just off Kensington High Street. The Hotel is close to Hyde Park, the stylish shops of Knightsbridge and Kensington and the Royal Albert Hall. The West End, Buckingham Palace, Piccadilly Circus, Trafalgar Square and the Houses of Parliament, in fact almost every major attraction, is within easy reach. Nightlife is no problem with cinemas, clubs and theatres all in the vicinity. The Hotel has numerous restaurants and bars. High Street Kensington Underground Station is a couple of minutes walk from the Hotel.

DIRECTIONS

BY AIR: From Heathrow Airport the ‘Heathrow Express’ should be taken to Paddington Station. This express train service operates every 15 minutes and the journey time is 15 minutes. o­nce at Paddington Station in central London a short taxi ride can be taken to the Kensington Palace Hotel off Kensington High Street. Alternatively the underground ‘tube’ can be taken from Paddington directly to High Street Kensington (4 stops o­n the Circle or District line). o­nce at High Street Kensington Underground Station the Hotel is a couple of minutes walk away.

BY TRAIN: All the main line stations connect with the London Undergound and participants can get the Undergroundto High Street Kensington.

BY ROAD: Car parking facilities in Young Street are available nearby but it is expensive.

HOW TO REGISTER-

To register please complete the registration form and forward with your payment to the:

EUROPEAN CONTINUING EDUCATION COLLEGE

24 Menlove Gardens North,

Liverpool L18 2EJ, U.K.

Telephone:+44 (0)151 737 1993 Fax: +44 (0) 151 737 1070

E-MAIL: REGISTER@ECEC.CO.UK [3]WEBSITE: WWW.ECEC.CO.UK [4]

All applications will be acknowledged and a formal V.A.T. receiptissued. Telephone reservations (+44 (0) 151 737 1993) or better Fax (+44 (0) 151 737 1070) or E-Mail (REGISTER@ECEC.CO.UK) to the Courses’ Secretary will be provisionally accepted and confirmed o­n receipt of the form.

REGISTRATION FORM –CURRENT REQUIREMENTS FOR CHEMISTRY AND

PHARMACY SECTIONS OF REGULATORY SUBMISSIONS

6^th, 7^th and 8^th March 2006, The Kensington Palace Hotel, Kensington, London, U.K.

Please charge to my q VISA q Mastercard/Eurocard q American Express

Card Number………………………………………………..Expiry Date…………………………………..

Name o­n Card………………………………………………Signature……………………………………..

EUROPEAN CONTINUING EDUCATION COLLEGE

24 Menlove Gardens North

Liverpool L18 2EJ, U.K.

Tel: +44 (0) 151 737 1993Fax: +44(0) 151 737 1070

E-Mail: register@ecec.co.uk [5]

www.ecec.co.uk

COURSES 2005/2006

    FOR FURTHER INFORMATION PLEASE CONTACT

Prof Mike Rubinstein

  Tel: +44 151 737 1993Fax: +44 151 737 1070

 E-MAIL: INFO@ECEC.CO.UK

                                                                             WWW.ECEC.CO.UK [6]