PIAT Newsletter. Issue 3. December 09.pub

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					                                                                                                           ISSUE 3
                                                                                                DECEMBER 09

                  PIAT NEWSLETTER
                    Welcome to the third issue of
                         the Newsletter.
All the PIAT team attended our exhibi-
tion stand at the British Pharmaceuti-
cal Conference (BPC 2009) from 6-9th
September at Manchester Central. We
had a busy time over the four days
and spoke to many old friends with
links with PIAT. We were involved with
Jane Nicholson of the Industrial Phar-
macist Group of the Pharmaceutical
Society in discussions to establish a
specialist group on formulation design,
process development, and manufac-
turing technology, in which PIAT could
supply training.
Later, in November Brian exhibited at
the Pharmig annual conference at the
Nottingham Belfry. This is a relatively
small meeting, approximately 80 par-
ticipants, but allows plenty of time for
discussions with PIAT microbiology               Nick, Janet and Brian ‘on duty’ with a selection of modules.
tutors and prospective stakeholders.

                          Clinical Trials Programme
The PIAT Clinical Trials programme has recently been accredited by the University. After commissioning
the module authors in October 2006, we finally took delivery of the last of eight modules in January
this year, allowing us to apply for accreditation of the whole programme. Progress is continuing in the
other three new programmes, 7 out of 10 Pharmaceutical Microbiology modules have been written, 4
out of 9 Toxicology and 7 out of 8 in Pharmaceutical Business and Licensing.

                             New Module Tutors
For a long time PIAT has endeavoured to appoint the most experienced and qualified experts in their
fields, and we are now experiencing staff turnover at greater levels due to retirements, particularly in
the original Industrial Pharmacy programme. Last year Geoff Farrell retired after 60 years as an indus-
trial pharmacist, and until his last year was still active as a consultant. He has been replaced by Jane
Nicholson who now tutors Module 11— Regulatory Affairs. Jane has spent a professional lifetime in
regulatory affairs, mainly with Bristol-Myers Squibb, and is a founder member of the British Institute of
Regulatory Affairs, and a fellow of TOPRA.
Module 4 on Solid Dosage Forms, and Module 7 on Controlled Release Dosage Forms are currently be-
ing rewritten and amalgamated to form one new module, by Chris Moreton (Vice President of FinnBrit
Consulting, and previously VP of Idenix Pharma) with widespread industrial experience in a further
number of companies. He has published and presented lectures and courses extensively in the indus-
trial pharmacy environment. He is expected to take over as module tutor within the next year.
Page 2
                                                                                        PIAT NEWSLETTER
                                                                                     ISSUE 3. DECEMBER 09

MSc in Modeling                                 Louisa Harvey, MSc —on
and Simulation on                               her experiences
Pharmacokinetics                                studying PIAT
                                                I have thoroughly enjoyed studying for my MSc in Indus-
Pharmacodynamics                                trial Pharmaceutical Science (PIAT). I particularly liked
                                                the flexibility to choose modules from anywhere in the
                                                programme; I chose 4 in clinical trials and 4 in formula-
Leader of this Sheffield University pro-
gramme, Professor Amin Rostami, has
recently taken up a position of Professor       I would definitely recommend PIAT for anybody in the
in Systems Pharmacology at Manchester           Pharmaceutical Industry who would like to have a good
and is in the process of transferring the       knowledge of many different areas; I have found it really
course to Manchester. The format and            useful in all aspects of my work at Napp. It has been a
subject matter is very similar but comple-      fantastic foundation for my career in the Pharmaceutical
mentary to the PIAT programmes, and we          Industry. I was quite unusual having not worked in for-
are pursuing accreditation with the aim to      mulation; however I did not feel I was disadvantaged in
run it alongside PIAT by September 2010,        any way. The modules are well structured and tell you
allowing students to select modules from        exactly where to find relevant information.
either or both programmes.                      Janet and Nick in the PIAT office are absolutely great.
                                                They are always at the end of phone to answer any que-
                                                ries, and really make you feel at ease especially around
                Visits                          exam time.
                                                If I had to recommend a book to help you understand the
Brian Lockwood visited James Henton at
                                                modules, I would recommend the book by M.E. Aulton,
Vectura, Chippenham, in September and
                                                Pharmaceutics: The Science of Dosage Form Design, it
met the Site Director and HR Director who
                                                was absolutely brilliant; I would never be without it!
were enthusiastic about sending further
staff on PIAT courses.                          p.s. see Book Review, Issue 2 for more info...

    Developments in
         PIAT                                   Book Review—Handbook of
PIAT has submitted proposals for a new          Pharmaceutical Excipients
programme of CPD modules for staff in
                                                Ray Rowe, Paul Sheskey, & Marian Quinn (eds.) Hand-
the pharmaceutical industry. We are cur-
                                                book of Pharmaceutical Excipients. 6th Edition.
rently in discussion with the University
about how to proceed but are likely to ask      This new 6th edition contains 340 fully referenced mono-
for funds for consultancy to investigate        graphs, written by industry experts, including an extra 40
the possibility of roll out of PIAT Lite into   since the 5th edition. The monographs contain structural
Europe.                                         and empirical formulae, description, specifications, appli-
                                                cations and references to pri-
                                                mary sources of data. In addi-
         PIAT Promotion                         tion, most monographs include
                                                scanning electron micrographs
                                                and Near Infra Red spectra.
Dr Sally Freeman, Chair of the Industrial       Commercially useful information
Pharmacy Board, was promoted to Reader          includes international names,
in July.                                        synonyms, suppliers, and de-
This is a very well earned promotion as         tails on grades available. As
she deserves it for her long standing con-      with an increasing number of
scientiousness and willingness to help          PharmPress publications, it is
anyone in the School.                           available as book or CD-ROM,
                                                and as a component of Medicines Complete.
                                                                                                   Page 3

TICTAC – The UK’s Leading Drug Identification
TICTAC is a comprehensive CD-ROM database for the visual identification of drugs (primarily Tablets
and Capsules) and substances that may resemble drugs. TICTAC is most commonly used by healthcare
and law enforcement professionals and by the pharmaceutical industry. It was developed by John Ram-
sey and Jean Wooley at the Toxicology Unit, St George’s Hospital Medical School, London, and is up-
dated quarterly.

TICTAC’s extraordinarily versatile and easy-to-use search facilities are specifically designed to help
healthcare and law and order professionals make swift and accurate identification of tablets, capsules
and many other products from their physical appearance. The comprehensive database also assists the
identification of drug-containing products (mostly tablets, capsules and transdermal devices) such as
ethical, generic, over the counter, prescription only, veterinary products, vitamins and food supple-
ments, herbal remedies, illicit drugs, parallel imports, and products that might be confused with them
(e.g. confectionery) from a physical description.

TICTAC is fully indexed and searchable, which makes visual confirmation simple with its extensive im-
age library of over 65,000 colour photographs including; 24,478 products, 3,630 medicines, 1,081
companies, 65,000 images and 109 medicine monographs

TICTAC also contains free access to the most authoritative and up-to-date UK medicines information
website, the eMC, which contains SPCs and Patient Information Leaflets (PILs), Monographs, and
Syva® Emit® Urine Drug Assays with Cross-reactivity Data.

Pharmacists may use TICTAC to; help them find an alternative source of product, produce a list of
products by active ingredient, enable them to identify an unknown tablet or capsule, identify a tablet or
capsule that has been taken as a suspected overdose, and enable them to identify a tablet or capsule
quickly in order to carry out the correct treatment — and to save money that would otherwise be spent
on identifying the product by another source.

TICTAC can be useful as a virtual pharmacy, and pharmaceutical companies – who are continually mak-
ing and marketing new products may use TICTAC to; check the uniqueness of proposed new markings,
logos, and product designs, act as a market intelligence tool (for example, to find out who sells whose
products), enable them to identify an unknown tablet or capsule, and assist in markings and design for
products used in clinical trials and for new commercial products.

The advantages of using TICTAC include being frequently updated, intuitive Windows
interface, flexible search strategy, comprehensive database, and full colour pictures
of all products.

A typical scenario for tablet identification involves imputing either some or all of the   The tablet is 9.1mm
product features, appearance, logos, manufacturer’s name, or even the colour.              by 3.4mm and
                                                                                           weighs 225mg

Another scenario could be identification of manufacturer using specific markings on
the formulation.

In Manchester we routinely use it for final year student projects to evaluate accuracy and we also used
it to demonstrate its effectiveness to the Greater Manchester Police as part of their Safer Clubbing Ini-
tiative for identification of amnesty bin contents and those of later seizures.

                                                     Further information is available at www.tictac.org.uk
Page 4
                                                                                                  PIAT NEWSLETTER
                          Biography – Linda Ambrose                                            ISSUE 3. DECEMBER 09

                    Linda has worked extensively in the Pharmaceutical industry for over 35 years, at
                    shop floor and director level, in QA and Manufacturing in small generic companies as
                    well as large multi-nationals. She’s also worked in the public sector and as a Regula-
                    tor (Group Manager MCA — as MHRA was then!) Medicines Inspectorate. She be-
                    lieves that all round multi-faceted perspectives help her deliver cost effective people
                    oriented approach to Quality Management and operational improvements.
                    She has a deep understanding of the role of the Qualified Person having conducted
                    independent research into this together with occupational psychologists. She is the
                    proud holder of Certificate of Eligibility number 001 issued by the 3 professional bod-
                    ies under the permanent arrangements in UK in 1994.
With Post Graduate qualifications in Psychology & Change Management and an MBA, Linda is convinced
that people are the core of most operational inefficiencies and problems with quality management
within the industry.
She is committed in her consultancy (Ambrose Consulting Ltd, established in 1997) to bring about op-
erational improvements through people development and is passionate in developing her client’s Quality
Functions to add value to the organisation. “Unfortunately,” she says, “QA professionals are often re-
cruited and promoted through their technical competences rather than business or leadership acumen.
So we recruit people with a propensity for compliance (acting in accordance with the rules) and then
expect them to develop generative business value-added QMS.” She focuses her work as much as pos-
sible on what she calls “the People Factor”!
Having called Thailand “home” for the last 6 years, Linda is very keen to use her cross-cultural aware-
ness gained during studies and working across Asia, to help organisations in the emerging markets to
improve their operational and QMS standards and to help produce cost effective medicines for all.
As well having qualifications in Swedish & Thai Massage, she is a Tai Chi aficionado having studied in
China with a 16th generation Tai Chi Master. Linda is deeply interested in Integrative, Functional Medi-
cine and Eastern Philosophy.

PIAT Graduands—Diploma                                             FUTURE ISSUES…
                                                                   •        History of PIAT
and MSc 2009—2010                                                  •        Role of a member of an MHRA Com-
Louisa Harvey, MSc with Distinction                                         mittee
Sharon Groves, MSc with Merit                                      •        Biography of Professor Bill Dawson
Ernie Woodhouse, MSc with Merit
Vandana Lad, Diploma with Merit
Kostas Liaros, Diploma with Merit
Sameh Qandilo, Diploma Pass

Marvin Woodhouse MSc (Almac) and his wife from Belfast, attended
the July ceremony as part of a tour around the UK mainland.

                                                                       An unsympathetic flash drawing of the PIAT Direc-
                                                                       tor, supplied by Pharmacist Support at BPC 2009.

                                                                                                      Brian Lockwood
                                                                                                      Director of PIAT
                                                                                                       December 2009

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