Untitled Document

Curriculum Vitae

Pia Hein Branebjerg. M. Sc. Pharm.
GCP Clinical Quality Assurance Auditor
1 February 2005

Education

1995 DTI (Danish Institute of Technology). Quality System Lead Auditor Training Course. Passed the examination as ISO 9001 Lead Auditor. Certificate No.: QM/1739/010

1982 M. Sc. Pharm. The Danish University of Pharmaceutical Sciences.

1976 Student at the Royal Danish School of Veterinary Science. (Stud. Med. Vet.).

1976 General Certificate of Education, A-level in science from Roskilde High School. Denmark

Employments

April 1999 Established the company “GCP Consult A/S” as an independent GCP QA consultant for the pharmaceutical industry.
A variety of GCP audits (both client and investigator site audits) has been conducted in most European countries and USA.
Clinical quality assurance systems have been established for several clients, including preparation and review of SOPs.
Training in ICH GCP and other clinical ICH guidelines has been provided in connection with the establishment of a Quality System or training for moni-tors based on audit observations.
Member of BARQA (British Association of Research Quality Assurance), ICR (The Institute of Clinical Research), SQA (Society of Quality Assurance), Danish Society of GCP, and Danish Quality Group for GCP.

Aug. 1997
Nycomed Pharma A/S, Roskilde, Director, Head of GCP Quality Assurance.
• Responsible for establishing a QA-GCP audit function in Nycomed Pharma.
• Responsible for the conduct of QA-GCP audits. The types of audits were primarily internal sponsor audits in the Medical and Biometrics depart-ments, investigator site audit and CRO audits in European countries. (Denmark, Norway, Austria, UK, Germany, Belgium, and Greece).
• Provided GCP and SOP training to the staff in the medical department.

Nov. 1991 Novo Nordisk, Regulatory Affairs Department. Registration Officer.
• Responsible for preparation and maintenance of the medical sections of marketing applications for USA, Europe and South Africa.

Dec. 1985 DAK-Laboratories A/S, Copenhagen, Clinical Department, Clinical Research Associate.
• Responsible for protocol preparation, trial initiation, monitoring, and clinical trial report writing for various projects.
• Responsible for implementing GCP in the clinical department. Respon-sible for preparing and implementing clinical SOPs and training in GCP and SOPs.

Dec. 1982 Astra-Syntex Pharmaceuticals A/S, Copenhagen, Clinical Department, Clini-cal Research Associate.

Courses

2004 EMEA. EudraVigilance User Training Course.

2004 Qualogy. Advanced Quality Assurance. “Moving beyond compliance”.

2003 Institute of Clinical Research. The Essentials of Phase I Clinical Research

2001 BARQA. Regulatory Compliance and Computer Systems

1998 BARQA. GCP Auditing. A Practical Approach.

1994 DIA. Practical GCP Compliance Auditing.

1992 PUF. Preparation of a Registration File.

1989 Oxford workshops. Danish Society of GCP. Syllabus for GCP workshop.

1988 The Association of the Danish Employers: Management.

1988 Medif/Mefa. Clinical trials.

1987 The Centre for Professional Advancement. Preparing clinical trial protocols and GCP

1986 DIEU. Project Management – strategy and organisation.

1986 Apotekersocieteten. Clinical trials monitoring.

1982 Astra-Syntex. Internal course in clinical trial monitoring

1995	DTI (Danish Institute of Technology). Quality System Lead Auditor Training Course. Passed the examination as ISO 9001 Lead Auditor. Certificate No.: QM/1739/010
1982	M. Sc. Pharm. The Danish University of Pharmaceutical Sciences.
1976	Student at the Royal Danish School of Veterinary Science. (Stud. Med. Vet.).
1976	General Certificate of Education, A-level in science from Roskilde High School. Denmark

April 1999	Established the company “GCP Consult A/S” as an independent GCP QA consultant for the pharmaceutical industry. A variety of GCP audits (both client and investigator site audits) has been conducted in most European countries and USA. Clinical quality assurance systems have been established for several clients, including preparation and review of SOPs. Training in ICH GCP and other clinical ICH guidelines has been provided in connection with the establishment of a Quality System or training for moni-tors based on audit observations. Member of BARQA (British Association of Research Quality Assurance), ICR (The Institute of Clinical Research), SQA (Society of Quality Assurance), Danish Society of GCP, and Danish Quality Group for GCP.
Aug. 1997	Nycomed Pharma A/S, Roskilde, Director, Head of GCP Quality Assurance. • Responsible for establishing a QA-GCP audit function in Nycomed Pharma. • Responsible for the conduct of QA-GCP audits. The types of audits were primarily internal sponsor audits in the Medical and Biometrics depart-ments, investigator site audit and CRO audits in European countries. (Denmark, Norway, Austria, UK, Germany, Belgium, and Greece). • Provided GCP and SOP training to the staff in the medical department.
Nov. 1991	Novo Nordisk, Regulatory Affairs Department. Registration Officer. • Responsible for preparation and maintenance of the medical sections of marketing applications for USA, Europe and South Africa.
Dec. 1985	DAK-Laboratories A/S, Copenhagen, Clinical Department, Clinical Research Associate. • Responsible for protocol preparation, trial initiation, monitoring, and clinical trial report writing for various projects. • Responsible for implementing GCP in the clinical department. Respon-sible for preparing and implementing clinical SOPs and training in GCP and SOPs.
Dec. 1982	Astra-Syntex Pharmaceuticals A/S, Copenhagen, Clinical Department, Clini-cal Research Associate.

2004	EMEA. EudraVigilance User Training Course.
2004	Qualogy. Advanced Quality Assurance. “Moving beyond compliance”.
2003	Institute of Clinical Research. The Essentials of Phase I Clinical Research
2001	BARQA. Regulatory Compliance and Computer Systems
1998	BARQA. GCP Auditing. A Practical Approach.
1994	DIA. Practical GCP Compliance Auditing.
1992	PUF. Preparation of a Registration File.
1989	Oxford workshops. Danish Society of GCP. Syllabus for GCP workshop.
1988	The Association of the Danish Employers: Management.
1988	Medif/Mefa. Clinical trials.
1987	The Centre for Professional Advancement. Preparing clinical trial protocols and GCP
1986	DIEU. Project Management – strategy and organisation.
1986	Apotekersocieteten. Clinical trials monitoring.
1982	Astra-Syntex. Internal course in clinical trial monitoring