Helén Larhammar

25 years of chemical-pharmaceutical and regulatory experience from the Swedish Medical Product Agency, pharmaceutical industry and CRO (Contract Research Organisation). Worked as expert in pharmaceutical biochemistry, both in the laboratory and as assessor, competence development and quality manager, documentation manager, project manager and as head/director of departments.

Employer:	Larhammar Consulting AB Uppsala, Sweden
Position:	Managing Director, Senior Regulatory Consultant
Time period:	January 2006 - Present
Description:	• Provide regulatory support in development projects • Advice on regulatory strategies • Review and gap analysis of documentation for clinical trial and marketing authorisation applications • Prepare, submit and follow-up of clinical trial applications • Liase with regulatory agencies. • Follow-up of EU, FDA and national regulations, directives and guidelines • Regulatory Affairs presentations and seminars

Employer:	Quintiles AB, Nordic Region, Uppsala, Sweden
Position:	Director of Regulatory Affairs
Time period:	January 1998 - May 2005
Description:	• Provide management and leadership for the Regulatory Affairs group in the Nordic Region. • Manage the resources and training required to provide Quintiles AB and customers with expert regulatory affairs services. • Business development activities including presentations of Quintiles regulatory services to customers. • Liase with Nordic regulatory agencies.

Employer:	Quintiles AB, Nordic Region, Uppsala, Sweden
Position:	Regulatory Affairs Manager
Time period:	September 1997 - December 1997
Description:	• Provide regulatory support in development projects • Advice on regulatory strategies • Prepare, write and review pharmaceutical expert reports • Prepare, submit and follow-up European clinical trials applications • Liase with Nordic regulatory agencies • Follow-up of EU and national regulations

Employer:	Astra Arcus AB, Sweden
Position:	Project Manager & Documentation Manager
Time period:	September 1995 - September 1997
Description:	• Manage the pharmaceutical team, 6 persons, and co-ordinate with the development project team. • Review, write some of and compile the Part II (chemical and pharmaceutical) documentation for a Monoclonal antibody and one CNS project • Write pharmaceutical expert reports for infection and CNS products

Employer:	Swedish Medical Products Agency (MPA)
Position:	Quality Assurance Manager
Time period:	August 1993 - September 1995
Description:	• Work on the Total Quality Management system (TQM) for the MPA

Employer:	Swedish Medical Products Agency (MPA)
Position:	Internal Consultant for Competence Development
Time period:	September 1992 - September 1995
Description:	• Co-ordinate and develop a Competence Development system for integration of different disciplines into one system of project management. • Initiation of appraisals and personal development plans for the entire staff

Employer:	National Board of Health and Welfare, Sweden (later MPA)
Position:	Head of Biochemical Section
Time period:	December 1986 - August 1992
Description:	• Managing the team • CTA’s and MAA’s • Laboratory control of peptides, proteins, allergens and biotechnological products by various biochemical techniques.

Employer:	National Board of Health and Welfare, Sweden Jan 1984 – Nov 1986
Position:	Pharmacist in Biochemistry
Time period:	January 1984 - November 1986
Description:	• Assessing the pharmaceutical part of CTA’s and MAA’s • Laboratory control of peptides, proteins, allergens and biotechnological products by various biochemical techniques.

Employer:	Institution of Pharmaceutical Biochemistry, Biomedical Centre Uppsala, Sweden
Position:	Research associate in Biochemistry
Time period:	October 1980 - December 1983
Description:	• Develop various biochemical techniques to analyse macromolecular impurities in penicillin preparations and error peptides in polypeptides and proteins. • Study the immunogenicity of various impurities in peptides and proteins (immunoglobulines, insulins and small peptides)

University:	Uppsala Universitet
Time period:	1980
Degree:	Pharmacy, MSc

Articles:

Kangefjärd, H., Karlsson, T. and Björkstén,B. Serum IgE antibodies in mice after immunization with ragweed extract and honey bee venom, employing a mouse RAST and mouse PRIST technique. Project Report no L 333 C17, Department of Biomedical Research, Pharmacia Ltd.(1980) Björkstén, B. and Kangefjärd, H. Serum IgE antibodies in sensitized mice after treatment with PEG modified ragweed extract and honey bee venom. Project Report no 333 C18, Department of Biomedical Research, Pharmacia Ltd.(1980) Kangefjärd, H. och Sjöholm, I. Antigena makromolekylära föroreningar i perorala penicillin- preparat. Abstract (poster), Farmacevtisk Årskongress, Stockholm, oktober 1982. Larhammar, H. och Sjöholm, I. Makromolekylära antigener i perorala penicillinmixturer. Information från Socialstyrelsens läkemedelsavdelning, 1983:6. Larhammar, H., Sjöholm, I., Skoog, B. And Wichman, A. Comparative conformational analysis of human somatotropin and biosynthetic methionyl human somatotropin by spectroscopic titrations. International Journal of Pharmaceutics, 23 (1985) 13-23. Larhammar, H. M Development of Quality Management at the Medical Products Agency in Sweden. Drug Information Journal 28 (1994) 949-956

Hobbies:	Singing jazz, pop, barbershop
Memberships:	Swedish Academy of Pharmaceutical Sciences Drug Information Association
Awards:	Nordic Champion in quartet barbershop singing 1999 International Small Chorus Award in barbershop singing 2007