Meet Our Director
Amer Alghabban,
M.Sc. Pharmacol. Post. Grad. Cert. Clin. Res., Dipl. Bio. Sci., B.Sc., IRCA ISO Certified
Managing Director
GxP Compliance & Training Partners (GCTP) Ltd
Background
Having initially completed an M.Sc in Pharmacology (Bradford University), Amer went on to complete his Postgraduate in Medical Sciences (University College Hospital), followed by a Diploma in Biological Sciences (Salford University) and a Postgraduate Certificate in Clinical Research (Surrey University).
This, in addition to his 31 years’ of extensive experience within all areas of GxP compliance led to the formation of GxP Compliance & Training Partners (GCTP) Ltd.
GCTP was originally established with the objective of helping pharmaceutical companies & academic institutions worldwide achieve end-to-end compliance (GCP, GVP, GCLP, GDP and GLP) in mind. It has come a long way since then by also becoming a Globally acclaimed Training Provider in it's own right.
Pioneering Accomplishments
Over the years, Amer's list of accomplishments have grown exponentially and continue to accrue - even now.
Yet, the achievements that hold most significance have been those that were unprecedented and standard-setting in nature.
He also went on to write the first EU regulatory authority SOPs on conducting GVP inspections.
To have someone with Mr Alghabban’s QA expertise in all stages of drug development from pre-clinical studies compliance through clinical development and through to post-marketing is indeed extremely unusual worldwide.
Leon Hooftman, M.D.
Mr. Alghabban also coordinated, personally hosted and followed up a series of pre-approval FDA and EMA regulatory authority inspections. His achievements then paid dividends when Arpida was inspected by the FDA and passed with neither Critical nor Major GCP or GVP or GLP Compliance findings
Khalid Islam, Ph.D.
Mr. Alghabban was chosen for the assignment due to his professional reputation and proven track record of being one of the world leading top experts in the field of Clinical Quality Assurance and Pharmacovigilance. The contributions Mr. Alghabban has made to the Acino group were invaluable of extraordinary value and benefit to the company and my organization. I can highly recommend him even for the most challenging assignments in pharmaceutical quality assurance.
Stefan Bier
Amer Alghabban has received remarkably positive feedback as a pharmacovigilance compliance expert; his skill in this area is truly outstanding.
Bindu Kapur-Campbell From my personal experience working with Amer Alghabban, I have a positive impression on his exemplary professional and personal attitude, his excellent professional qualification and long-standing experience, and have no hesitation whatsoever to recommend him for engagement as QA professional.
Dr Michael BauerTraining Achievements
In addition to providing an unparalleled level of service, Amer enjoys imparting his knowledge and invaluable experience through training platforms and has been delivering training on GxP QA, Clinical Development & Operations and Pharmacovigilance for over 25 years.
Amer's unique ability to effectively translate and deliver decades worth of GxP QA experience into intelligible & effective training content was recognised early on when he was handpicked to become the first invited Course Principal of the Pharmacovigilance Auditing Course delivered by U.K. Research Quality Assurance (RQA).
The Training quality delivered by Amer has been recognised globally and has subsequently led to GCTP being awarded "Best Trainer" for distinctive training standards.
Owing to these distinctive Training standards, several Pharma and Biotech companies have designated Amer as their Principal GxP Trainer within their respective Organisations.
Regulatory Compliance
In addition to experience working on the Regulatory side for organisations such as MHRA and RQA, Amer also has over 28 years’ experience/expert interpretation of regulations (US, EU, MENA, Eastern Europe & Asia) and respective Guidance/Standards of GCP, GLP, GCLP, GDP, GLP & GVP of Pharma, Biotech & Medical Devices & ISO 9001 & 13485. Medical device Field Actions & complaints management.
Amer has over 22 years’ experience of directing and hosting Inspection Readiness Programs (Mock Inspections and Pre- / Post-Mock Inspection-Training).
His other previous positions include:
- Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. USA,
- Global Director, Head of Quality Assurance at Merck Serono, Switzerland,
- Global Head of GxP Quality Assurance at Arpida Ag., Switzerland,
- Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Switzerland.
In addition to his role as Managing Director of GxP Compliance and Training Partners (GCTP), he is a consultant for several pharma and CRO companies.
Other Achievements
As well as his certification as a Lead Auditor by the International Register of Certified Auditors, Amer is also a member of several industry organisations.
This includes serving as an Executive Committee Member of International Society of Pharmacovigilance (ISoP) and the Good Pharmacovigilance Practice Committee of the British Association of Research Quality Assurance (RQA - previously BARQA).
Amer is also a member of the Society of Pharmaceutical Medicine, Associate of the Institute of Quality Assurance (IQA), DIA, Member of the Association of Clinical Research Professional (ACRP), and the Organization for Professions in the Regulatory Affairs (OPRA). He is also a member of CMO Outsourcing & Management, QA & RA Network.
Publications
Amer is the writer of two published reference books, "The Pharmaceutical Medicine Dictionary" and "The Dictionary of Pharmacovigilance" and is currently writing his third book, "Dictionary of Clinical & Pharmaceutical Development".
In addition, to writing several other publications, Amer was the Assistant Editor for 11 medical journals.
I have been exposed to the best and brightest of the industry and it is with this experience that I am able to make the judgment that Mr. Alghabban stands out as exemplary. Mr Alghabban is one of the best and most unique talents I have come across in my many years in the biopharmaceutical business.
Tracey Marshall Senior Director, Clinical Operations,