european Industrial Pharmacy 2008 – 2010

ISSUE 7 • OCTOBER 2010
European Industrial Pharmacy
Editorial Comment
Gino Martini

Pharmaceutical Industry Advanced Training (PIAT) – accredited professional development for the medical and healthcare industries
Brian Lockwood
The PIAT programme provides a distance learning opportunity to experience continuing professional development (CPD).

Hot-melt extrusion technology: optimizing drug delivery
Marcia Williams, Yiwei Tian, David S Jones and Gavin P Andrews
Hot-melt extrusion is a new technology used to produce a variety of solid dosage forms which offer increased dissolution properties and hence improved absorption and therapeutic efficacy for poorly water-soluble compounds.

Moving toward 100% raw material inspection with a handheld Raman spectrometer
Robert L Green and Christopher D Brown
Improvements in Raman spectroscopy and the development of handheld instruments makes it an attractive alternative to traditional raw material inspection methods.

The QPPV – cementing the pharmacist’s role in Europe
Derek Woodcock
Why are there so few pharmacists in the UK who are Qualified Persons in Pharmacovigilance (QPPV)? The author, a pharmacist QPPV himself, urges pharmacists to consider this career.

Diagnostics and their role in personalised medicine
Loïc Kubitza
Biomarkers and diagnostics are playing an increasing role in improving the design and probability of success of clinical trials. They are also becoming more important in improving individual treatment.

Regulatory Review
Malcolm Holmes

News From The EIPG
Jane Nicholson

Pharmaceutical Forum

Job Vacancies

Dates For Your Diary

Read Issue 7   

ISSUE 6 • JUNE 2010
European Industrial Pharmacy
Editorial Comment
Jane Nicholson

The PHARMINE paradigm – matching the supply of pharmacy education and training to demands
Jeffrey Atkinson and Bart Rombaut
The move from big pharma based on chemical synthesis to smaller enterprises based on biotechnology will have a major impact on education and training for industrial pharmacists.

The importance of the industrial academic interface for innovation in the pharmaceutical sector
Mike Eaton
Industry and academia need each other. More effort to improve communication is needed from the industrial sector, and the academic sector should be encouraged to find original solutions to serious healthcare problems.

Biopharmaceuticals – from niche to mainstream
Gareth Williams
A survey of biopharmaceutical companies shows that a large majority of the independent sector have concerns about mergers with traditional pharmas, biosimilars and the current patent system.

Peristaltic pumps – an answer to increasing demands within the biopharma industry
Henrik Ejsing
These have a number of advantages over standard pumps especially when it comes to cleaning and cleaning validation. There is also no risk of cross-contamination and just a short changeover time.

Stability programs need to be re-invented
Patrick Crowley
Companies should be aware of the possibility of unexpected contaminants – even in secondary packaging material or storage pallets.

Regulatory Review
Malcolm Holmes

News From The EIPG
Jane Nicholson

Pharmaceutical Forum

Job Vacancies

Dates For Your Diary

Read Issue 6   

ISSUE 5 • FEBRUARY 2010
European Industrial Pharmacy
Editorial Comment
Gino Martini

EIPG Guidance On CPD For Regulatory Affairs
EIPG Regulatory Affairs members from France, Germany and UK
The European Industrial Pharmacy Group (EIPG) has prepared a Continuing Professional Development (CPD) Guidance for regulatory affairs professionals.

Pharmacy Education In Hungary
Sylvia Marton
Pharmacy education in Hungary has a long history and a great tradition. Professor Marton gives details of the curriculum, especially postgraduate education, whether for specialisation or for a doctoral degree.

Surface Analysis Exposes Counterfeit Medicines
Justine Bentley
A technique from analytical chemistry could be useful in detecting counterfeit tablets.

ChondroCelect: The First Advanced Therapy Medicinal Product In Europe
Tom Sam
A tissue engineered product for repairing damaged cartilage is the first to be approved by EMEA under the new ATMP regulation.

In Situ Gel-Forming Systems For Sustained Ocular Drug Delivery
Mahesh N Mali and Ashok A Hajare
Topical application of an ophthalmic product provides poor bioavailability. This can be overcome using a solution that shifts to a gel-form under certain physiological conditions.

Regulatory Review
Steve Fairchild

News From The EIPG
Jane Nicholson

Pharmaceutical Forum

Job Vacancies

Dates For Your Diary

Read Issue 5   

ISSUE 4 • OCTOBER 2009
European Industrial Pharmacy
Editorial Comment
Gino Martini

The Potential Impact Of ICH Q8, 9 & 10 On The Qualified Person
Richard Smalley
The QP is attracting more and more duties and responsibilities which will require more delegation and management involvement.

Framework For A Continuing Professional Development (CPD) – A UK Perspective
Fred Ayling
UK pharmacists wishing to register with the new General Pharmaceutical Council will need to commit to CPD and submit regular records. This article tells you why and how.

How To Achieve Effective Compliance With EU GMP Part II In API Manufacture
Norman Franklin
Dealing with practical aspects of compliance – an auditor’s tour of the QC laboratories.

Near-Infrared Spectroscopy: A Powerful Tool For PAT/QBD
Emil W Ciurczak
NIR has a wide range of applications in the pharmaceutical industry in production and quality assurance.

The Next Fifty Years: Developing Our Core Values For A Changing World
Pär Tellner
Report from PGEU symposium, Stockholm, 15 June 2009.

The Industrial Pharmacist’s Role In Providing Patient Information
Roland Schots
The importance of the pharmacist is emphasised.

Regulatory Review
Steve Fairchild

News From The EIPG
Jane Nicholson

Safer Medicines Supply – Anti-Counterfeiting Using 2-D Barcoding
Inger Näsman
The Data Matrix 2-D code is described.

Pharmaceutical Forum

Book Review
Ivana Silva

Job Vacancies

Dates For Your Diary

Read Issue 4   

ISSUE 3 • JUNE 2009
European Industrial Pharmacy
Editorial Comment
Gino Martini

Swedish Environment Classification Of Pharmaceuticals
Pär Tellner
The impact of the residues of medicines on the environment has been investigated in Sweden, resulting in an environmental risk classification.

Continuing Professional Development – The RPSGB And TOPRA Schemes
Tony Cartwright
The author compares the compulsory RPSGB scheme with the voluntary TOPRA one.

Biosimilars: Extending Biologicals’ Benefits
Mark Greener
Producing a generic biopharmaceutical is not as straightforward as producing a small molecule drug. It not only has to be bioequivalent but has to go through a much more rigorous clinical trial programme and very strict quality control.

Freeze-Drying Of Shaped Pharmaceutical Dosage Forms
Kerr H Matthews
A non-traditional capability of freeeze-drying shaped dosage forms needs an improved understanding of the scientific principles involved.

Making Superior Particles For Drug Delivery Using Power Ultrasound
Graham Ruecroft
Micronisation of large particles has many drawbacks, especially in the formulation of dry powder inhalers. Sonication technology using power ultrasound of 20-100kHz results in superior engineered drug particles, whose advantages are outlined in this article.

Web 2.0 – What Does It Mean To The Pharmaceutical Industry?
Marta Garrido
The rapidly changing ways in which interactive technology is enhancing communications for the consumer need to be examined and exploited by the pharma industry.

Management And Revision Of Documentation
Michael Hiob
An organisational structure is described followed by the stages of a document’s life cycle.

News From The EIPG
Jane Nicholson and Roland Schots

Regulatory Review
Steve Fairchild

Dates For Your Diary

Read Issue 3   

ISSUE 2 • FEBRUARY 2009
European Industrial Pharmacy
Editorial Comment
Gino Martini

Partnerships Create Value For Healthcare Customers
Mats Olsson and Pär Tellner
Pharma companies and healthcare professionals alike need to develop new marketing strategies to meet the new healthcare needs of their customers and patients.

Framework For A Continuing Professional Development (CPD) – A UK Perspective
Fred Ayling
The requirement for pharmacists to take part in a CPD programme is detailed and discussed.

Does Chance Favour The Prepared Mind?
Dave Sharma
Many of today’s drugs were discovered by chance. But as the well-known story of Sir Alexander Fleming’s discovery of penicillin shows, the true scientist is the one who questions anomalies.

Chocolate: A Therapeutic And Nutraceutical Delivery System
Tim Ridgway
The ingredients of chocolate have been shown to have a number of health benefits and so one should not feel guilty about eating it.

Vacuum Foam Drying: A New Technology For Preserving Sensitive Biomolecules
Ashok Hajare, Harinath More and Sambhaji Pisal
This technology has several advantages over freeze drying and is therefore worth further development.

Visions And Nightmares Of A Microbiologist
Klaus Haberer
The author urges the need for a re-evaluation and harmonization of microbiological test methods and comments on the need to rely on conventional pharmacopoeial methods.

Regulatory Review
Steve Fairchild

News From The EIPG
John Jolley

Dates For Your Diary

Read Issue 2   

ISSUE 1 • OCTOBER 2008
European Industrial Pharmacy
Editorial Comment
Gino Martini

Quality Charter For Medical Representative Visits
Valérie Lacamoire
This charter aims to strengthen the role of the medical representative visit in the rational use of drugs and in the quality of the information conveyed.

The Patient Journey – The Benefits Of Well-Informed, Targeted Guidance And Information
Marta Garrido
Easing the patient’s journey through diagnosis, procedures and medication benefits not only the patient but also physicians, pharmacists and drug companies.

Bio-Inspiration For New Pharmaceutical Sprays
Andy McIntosh
A beetle’s protection mechanism has inspired a physics department to develop a new form of drug delivery system.

Latvian Industrial Pharmacists
Inta Saprovska
An active and ambitious Section.

The Role Of The Qualified Person In The 21st Century
Joyce Ramsbotham
There are better ways to protect the patient than individual batch release.

Operation Stormgrand – A Tangled Web Of Worldwide Deceit
Joe Ridge
Counterfeit medicines have become a worldwide problem. This MHRA case history traces the complicated international network of a counterfeiting organisation.

Regulatory Review
Steve Fairchild

News From The EIPG

Dates For Your Diary

Read Issue 1