Professional Documents
Culture Documents
Michael Bonett
B.Pharm (Hons.), M.A. Integrated Marketing Communications
(0044/(0)74 68740022/ mbon008@yahoo.com / Born: 07/04/1977)
POSITIONS HELD
UK, Wokingham
January 2016 Present, J&J Medical, Quality and Regulatory Specialist Supply Chain
Quality Assurance (GDP, Suppiler Audits, Documentation Review, Quality Agreements)
Netherlands
March 2014 Dec 2015, UPS Quality Assurance and Regulatory Affairs Manager EMEA
Regulatory Affairs (EMEA Regulations, Improvement of Compliant Quality Systems)
Public Affairs (Healthcare Regulations EU, National, Medical Devices, Pharmaceuticals)
Quality Management (Healthcare Contract Logistics Supply Chain Hungary and Italy)
Quality Assurance Enterprise (Small Package, Freight - Certification, Audit, Analysis)
Business Development (Support with responses to requests for quotes/implementations)
Participation in Integration Projects for Acquisitions (Italy, Hungary, UK)
Malta
Project team (Medicines Regulatory Unit) to set-up a Medicines Authority, then
within the Medicines Authority itself.
Malta Regulatory Authority, Sep 2000 May 2006, Quality Assessor/Pharmacist
Assessment of product information according to EU regulations
Promotion (e.g. articles, presentations) of a national adverse drug reporting (ADR)
Setting up and maintenance of a national ADR Database and connection to the European
Eurdavigilance network and World Health Organisation ADR network
Processing, assessment & follow-up of spontaneous and clinical trial ADR reports
Design and implementation of a quality system to manage variations to product information
Conduction of training and participation in auditing team
Involvement is setting up systems to comply with EU directives requirements for clinical
trials and advertising of medical products
http://www.medicinesauthority.gov.mt/
EDUCATION
PHARMACY (BACHELOR)
1995 to 2000
COMMUNICATIONS (MASTERS)
2002 to 2004
TRAINING COURSES
Building Relationships, UPS, June 2013
Develop Yourself, Deliver Results, UPS, Sep 2011
GMPs in Storage, Transportation and Cold Chain, ECA, Mar 2012
Pharmaceutical GMP, DBA, Dec 2010
Good Distribution Practice Inspection, MCA, Nov 2002
MedDRA Structure and Functions, MSSO, SEP 2005
EudraVigilance User Training Course, EMEA, OCT 2004
Pharmacovigilance/IT study visit at the Irish Medicines Board (IMB), JUN 2002
Internal QMS Auditor Training Course, IQA Services Ltd., DEC 2004
Pharmaceutical Regulatory Affairs and Legal Issues, University of Malta, AUG 2001
Twinning Project (MHRA/IMB) Training
Communication, & Presentation Skills, Effective Meetings & Time Management, EU
Marketing Authorisation Applications, Quality Systems, & Pharmacovigilance
ADDITIONAL EDUCATION
COMPUTER STUDIES
Computer Literacy, Word Processing
MS ACCESS, Introduction
SPSS, Introduction
University of Cambridge
Staff Development, Office of Prime Minister
University of Malta
MANAGEMENT
Managing Change, People
The Economic Environment
European Union Studies
WHO CONFERENCES
PUBLICATIONS
A National Adverse Drug Reaction Reporting System for Malta, Malta Medical Journal, Oct
2004.
ADDITIONAL EXPERIENCE
LANGUAGES
English:
Maltese:
Italian:
French:
Dutch:
German:
INTERESTS
Travelling, Reading, Guitar/Music, Gym, Swimming/Fishing/Diving