Anthony C. Cartwright

Previous Employment

Director, Global Regulatory Solutions Ltd. – providing consulting, contracting and training services to the pharmaceutical industry and their advisers (January 2001 – January 2006).

Regulatory Affairs Advisor – self-employed independent contractor providing regulatory strategic and technical consulting services to clients (May 2000 to December 2000).

Senior Director, World-wide Regulatory Affairs, PAREXEL International Ltd. (March 1998 to May 2000).

Director World-wide Regulatory Affairs, PAREXEL International Ltd (January 1996 to March 1998)

Manager, New Chemicals and European Licensing Unit, Medicines Control Agency, Department of Health (to December 1995)

Superintending Pharmacist, Medicines Division, Department of Health (1990 to 1995)

Principal Pharmacist, Medicines Division, Department of Health (1978 to 1990)

Senior Scientific Officer, British Pharmacopoeia Commission, London (1974 to 1978)

Group Manager, Product Development Group, Cyanamid International Ltd., Gosport, Hants (responsible for R and D, clinical trial manufacture, bioavailability studies etc. for human and veterinary formulations) (1964 to 1974)

Senior Formulation Chemist, Miles Laboratories Ltd., Bridgend, Glamorgan, South Wales (responsible for areas of solid dose form, dermatological and diagnostic development)

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS:

Chairman, Quality Working Party, 1985 – 1991 Part of UK delegation to the CPMP (1980 – 1995) UK rapporteur for Multistate and Concertation applications UK delegate to CPMP Operational Working Party (1990 – 1994) ICH Co-ordinator (Quality) for CPMP (until 1994)

INTERNATIONAL CONFERENCE ON HARMONISATION:

Chairman, Quality Workshop, 1st International Conference on Harmonisation (1991)
Chairman, Expert Working Group (Quality) for ICH (1992 – 1994)

AWARDS:

Drug Information Association, Outstanding Service Award, June 1991

The Organisation for Professionals in Regulatory Affairs, Distinguished Service Award, October 2007.
Coeliac UK, Outstanding Achievement Award (Runner Up), July 2010. 

BRITISH PHARMACOPEIA COMMISSION:

Member, Committee C (General Chemicals), 1994 – 2015.

THE ORGANISATION FOR PROFESSIONALS IN REGULATORY AFFAIRS

Chairman, Lifelong Learning Committee, 2004 – 2009
Member, Professionalism Committee, 2009 – 2014

ROYAL PHARMACEUTICAL SOCIETY

Chairman, Retired Pharmacists Committee (2012 – 2015)

COELIAC UK

Member of Coeliac UK Health Advisory Network. 

PROBUS SECUNDUS, HARPENDEN

Member (2009 – present)

Committee Secretary (2010 – 2015)

Vice-Chairman (2014 – 2015)

Chairman (2015 – 2016) 

WORSHIPFUL SOCIETY OF APOTHECARIES

Yeoman Member 2015

Freedom of the City of London, December 2015 

CONFERENCES/TRAINING SEMINARS ETC.

Tony Cartwright has been involved in presenting at conferences and training seminars for about 30 years, and has spoken at conferences and courses organised by the DIA, EOQC, RAPS, ESRA, BIRA, TOPRA, IFB, AAPS, APV, PERI, RPSGB, Swedish Pharmaceutical Society, Finnish Pharmaceutical Society and other professional bodies. He led the Quality Workshop at the ICH1 conference, and presented at the plenary opening session of ICH2.

He has spoken for many commercial conference producers – particularly IBC Global Conferences Ltd (Informa), IBC Conferences US, Management Forum, Barnett (US) and others. He typically presented at about 10 – 15 conferences/training seminars per year.

He acted as one of the Course Directors for the IBC ‘Registration of Pharmaceuticals in Europe’ course for 18 years. This course was successfully presented in Europe, the US, Canada and Japan.

PUBLICATIONS:

Scientific Journals

Cartwright, A.C, Hatfield, H.L., Yeadon, A et al. A comparison of the bioavailability of minocycline capsules and film-coated tablets. J. Antimicrob Chemother, Sept 1975, 1(3), 317-322

Cartwright, A.C and Shah, C. An in vitro test for slow release potassium chloride tablets. J. Pharm Pharmacol, June 1977, 29(6), 367-369

Cartwright, A.C. Sources of variation during collaborative evaluation of in vitro dissolution tests for two solid preparations. J. Pharm Pharmacol, July 1979, 31(7), 434-440

Cartwright, A.C. Practical aspects of dissolution testing. Drug Dev Ind Pharm 5(3), 277-291, 1979

Anthony Cartwright, Mary Tomkins, Jenny Boncey, Christine Hastie, Rosalind Grant, Diane Leakey, Ian G. Simpson, Sarah Cockbill, Beth Taylor, Michael Beaman, Joan Craig and Carol Lange. Patient information on covid-19 – a vaccine centre lottery. BMJ 2021, 373n1310

Cartwright, A.C. Stability Testing – The Requirements of the United Kingdom Licensing Authority. Int. J. Pharm Tech and Prod Mfr, 1982, 3(2), 43-46

Cartwright, A.C. Bioavailability and Bioequivalence. Pharmacy International, 1984, 4(8), 196-198

Cartwright, AC and Jefferys, D.B. Regulatory Scene: Expert Reports for Product Licence Applications in Europe – A Regulatory Review. Pharmaceut Med, 1987, 2, 229-237

Cartwright, A.C. Stability Tests on Active Substances and Finished Products: New European Guideline. Drug Dev Ind Pharm, 1989, 15(10), 1743-1757

Cartwright, A.C. Introduction to CPMP Quality Guidelines. BIRA Journal, 1990, 9(3), 1-2

Cartwright, A.C. Harmonisation of European Requirements for Quality of Medicinal Products: Countdown to 1992. Pharm Tech International, 1990, 12-15

Cartwright, A.C. Company strategies in Europe: Successful Use of the CPMP Procedure. BIRA Journal, 1990, 9(2), 9 – 11

Cartwright, A.C. Toxicology of impurities in organic synthetic drugs. Int J. Pharm. 4(4), 146-149, 1990.

Cartwright, A.C. Regulatory implications: An authority’s perspective (on chiral drugs). Biochem Soc Trans. April 1991, 19(2), 465-7

Cartwright, A.C. International Harmonization and Consensus DIA Meeting on Biovailability and Bioequivalence Testing Requirements and Standards, Drug Information Journal, 1991, 25, 471 – 482

Anthony C. Cartwright, Manuel Zahn. The Format and Content of a Global Chemical/Pharmaceutical Documentation – A Proposal. Drug Information Journal, 29(4), 1225-1235 (1995)

Blume, H., Cartwright, A.C., Möller, H. Setting Specifications for Drug Substances and Drug Products. Report on a Conference organised by the International Pharmaceutical Federation (FIP). 1996, Pharm Ind. 58(2), 1-8

Barnett, S.T., Croswell, R.W., Cartwright, A.C., and Grignolo, A. Organization and Responsibilities of the Chemistry, Manufacturing, and Controls Function Within Regulatory Affairs: A Survey of 17 Companies. Drug Information Journal, 1998, 32, 385-392

Forbes, A., Cartwright, A.C., Marchant, S., McIntyre, P., and Newton, M. Review Article: Oral, Modified Release Mesalazine Formulations – Proprietary versus Generic. Aliment Pharmacol Ther, 2003: 17, 1207-1214 Information

Tony Cartwright, Geoffrey Farrell, Brian Matthews, Alan Paul and Anne Wigmore, Drawing up a roadmap for your own personal career development, Regulatory Rapporteur 2(3), 12 – 15, 2005

Tony Cartwright, Meeting Report on Professionals Association Research Network (PARN) Conference on Continuing Professional Development (CPD), Regulatory Rapporteur 2(6), 30 – 31, 2005

Van Aerts, L.A.G.M, Kasper, P, Queckenberg, O, Mueller, L, Cartwright, A.C. International Workshop on Qualification and Control of Impurities. Drug Information Journal, 2006

Cartwright, A.C. Article on Lifelong Learning. TOPRA In Touch, July issue, 2006

Tony Cartwright, Key Competences for Regulatory Affairs Professionals, Regulatory Rapporteur 3(10), 9 – 12, 2006

Anthony C. Cartwright. The Electronic Common Technical Document. Int. J. Pharm Med 2006: 20(3), 140 – 158

Cartwright, A.C and Matthews, B.R. Profiles of Lifelong Learning (LLL) amongst TOPRA members: Analysis of results of subscription renewal questionnaires. Regulatory Rapporteur, 4, 2007.

Haynes, RK, Chan, LW, Lung, CM, Wong HN, Shek, LY, Williams ID, Cartwright A.C and Gomes, MF. Artesunate and Dihydroartemisinin (DHA): Unusual Decomposition Products Formed Under Mild Conditions and Comments on the Fitness of DHA as an Antimalarial Drug. ChemMedChem, 2(10), 1448-1463, 2007

Tony Cartwright. Continuing Professional Development – the RPSGB and TOPRA Schemes. Industrial Pharmacy 22, 8-10, June 2009 Fitness

Tony Cartwright and Bob Allison. Coeliac Disease: opportunities and challenges for pharmacists, Pharm J 283, 157,158 and 164, 8 August 2009

Tony Cartwright. Our daily bread (article on coeliac disease). NPA magazine InPharma May 2011, 20-21

D. Snodin, A.C. Cartwright, B.R. Matthews. Review of the Production Statement in monographs on mesylate salts in the Ph.Eur: why do we need GMP and a Production statement. Pharmeuropa Bio&SN, April, 1-10 (2012)

David Snodin, Tony Cartwright and Brian Matthews. Alkyl mesylate impurities: A case study in regulation. GMP Review 11(3), 9-11 (2012)

Tony Cartwright. The British Pharmacopoeia – happy 150th birthday to ’the chemist’s bible’. Pharm. J. 292 (7794), 86-89 (2014)

Tony Cartwright. Pharmacopoeial Harmonisation: An historical perspective. Industrial Pharmacy 43, 10-12, September 2014

Tony Cartwright. NHS controversy does no favours for coeliac patients. Pharm. J. 293(7882), 324 – 326 (2015)

Tina Krauss, Mathieu Marchivie, Thida Phoeng, Alexandra Gaubert, Amelie Desire, Giovanni Tonelli, Chantal Boyer, Marie-Helene Langlois, Anthony Cartwright, Melba Gomes, Nicholas White and Karen Gaudin. Preformulation studies of ceftriaxone for pediatric non-parenteral administration as an alternative to existing injectable formulations. European J. Pharmaceutical Sciences 104, 382-392 (2017)

Tony Cartwright. Is there a missing piece in the regulatory system? Industrial Pharmacy 57, 7-8 (2018) studies

Tina Krauss, Alexandra Gaubert, Luc Tabaran, Giovanni Tonelli, Thida Phoeung, Marie-Helene Langlois, Nick White, Anthony Cartwright, Melba Gomes, Karen Gaudin. Development of rectal self-emulsifying suspension of a moisture-labile water-soluble drug. International J of Pharmaceutics 536, 238-291 (2018)

Tina Krauss, Marie-Helene Langlois, Alice Guyonnet-Duperat, Thida Phoeung, Xiao Yu Xie, Anthony Cartwright, Nicholas White, Melba Gomes, Karen Gaudin. Development of Rectodispersible Tablets and Granulate Capsules for the Treatment of Serious Neonatal Sepsis in Developing Countries. Journal of Pharmaceutical Sciences 108, 2085-2813 (2019)

Anthony Cartwright, Mary Tomkins, Jenny Boncey, Christine Hastie, Rosalind Grant, Diane Leakey, Ian G. Simpson, Sarah Cockbill, Beth Taylor, Michael Beaman, Joan Craig and Carol Lange. Patient information on covid-19 – a vaccine centre lottery. BMJ 2021, 373n1310

Earlier Books, Book Chapters

Pharmaceutical Product Licensing: Requirements for Europe (with B. R. Matthews as co-author and co-editor), 1991 Ellis Horwood Ltd., ISBN 13-662883-4 (now available through Taylor and Francis)

Stability Testing in the EC, Japan and the USA: Scientific and Regulatory Requirements, edited Wolfgang Grimm and Kurt Krummen, 1993, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, ISBN 3-8047-1215-0. Chapter on ‘EC Guidelines for stability tests on active substances and finished products’

International Pharmaceutical Product Registration: Aspects of Safety, Quality and Efficacy, First Edition (with B. R. Matthews as co-editor), April 1994. Ellis Horwood Ltd., ISBN 0-13-47497-X (formerly available from Taylor and Francis, but now out of print)

International Stability Testing, Edited by David J. Mazzo, Interpharm Press Inc, 1999, ISBN 1-57491-078-7. Chapter on ‘Variations and Changes in Europe: Stability Requirements’

Medicines, Medical Devices and The Law, Edited by John O’Grady, Ian Dodds-Smith, Nigel Walsh and Michael Spencer, 1999, Greenwich Medical Media Ltd, IASBN 1-9001512-073. Chapter on ‘Medicines Regulation’.

International Pharmaceutical Product Registration, Second Edition. Editors: Anthony Cartwright and Brian R. Matthews, Informa USA, 2009. ISBN-10: 1-4200-8176-4