Gunnar Thor Gunnarsson
Pharmaceutical Regulatory Affairs Expert
Reykjavik
Summary
Accomplished pharmaceutical-science professional with an exceptional blend of scientific research and analysis, substance evaluation and assessment, and compliance expertise to support the development and approval of pharmaceutical products and substances. Recognized as an industry expert in pharmaceutical assessment with a history of success providing guidance to industry experts in the application and certification of new clinical drug substances and products. Adept at building strong working relationships with business partners, industry leaders, the academic community, and staff at all levels to further organizational and medical community goals. Excellent communication and leadership capabilities; well-versed in best practices, methodologies, and regulatory guidelines. Areas of expertise include: Drug Design Best Practices/Standards Evaluation Methodologies Regulatory Compliance Product Marketing Authorization Professional Development
Overview
25
25
years of professional experience
8
8
years of post-secondary education
1
1
Certification
Work History
Senior Pharmaceutical Assessor
ICELANDIC MEDICINES AGENCY
Reykjavik
01.2020 - Current
- Conduct comprehensive evaluations and assessments of active substance master files (ASMF), and Module 3, for subsequent marketing authorization of new drug substances and products in centralised and de-centralised procedures
- EMA Scientific advice: Provide guidance and advice to industry applicants to ensure process suitability, impurity control, and submission accuracy for new and future marketing authorisation applications
- Manage and evaluate new applications, and maintaining strict deadlines
- Developed and delivered training and workshops for new assessors / external assessor, internal guidelines and policy documents with focus on impurity controls and control strategy
- EMA Expert group on nitrosamines
- Manage and evaluate new clinical trial applications, and maintaining strict deadlines
Senior Pharmaceutical Assessor
DANISH MEDICINES AGENCY, LÆGEMIDDELSTYRELSEN
Copenhagen
01.2016 - 06.2022
- Pharmaceutical Quality
- Conduct comprehensive evaluations and assessments of active substance master files (ASMF), and Module 3, for subsequent marketing authorization of new drug substances and products in centralised and de-centralised procedures
- EMA Scientific advice: Provide guidance and advice to industry applicants to ensure process suitability, impurity control, and submission accuracy for new and future marketing authorisation applications
- Manage and evaluate new applications, and maintaining strict deadlines
- Served as external expert at EDQM for Certification Division; granting of CEPs
- Developed and delivered training and workshops for new assessors / external assessor, internal guidelines and policy documents with focus on impurity controls and control strategy
- Manage and evaluate new clinical trial applications, and maintaining strict deadlines
- External expert from 2020, focus on reducing backlog of applications
Program Scientific Officer
EUROPEAN DIRECTORATE, QUALITY OF MEDICINES AND HEALTHCARE
Strasbourg
03.2012 - 01.2016
- Conduct comprehensive evaluations and assessments of ASMF, as integral part of certification of suitability (CEP) for European Pharmacopoeia – Chemical and Herbal
- Provided guidance and advice to industry applicants to ensure process suitability, impurity control, and submission accuracy for new dossier applications
- Managed and evaluated new applications, including coordinating other expert assessments, communicating with submitting companies and applicants, and issuing certificates
- Developed and delivered internal training for new assessors to ensure and understanding of best practices and protocols; drafted all guidelines and policy documents to maintain highest integrity and mitigate risk
- Represented organization at industry conferences and meetings, charged with meeting with stakeholders, introducing CEP procedures, and providing guidance.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork
- Developed and maintained courteous and effective working relationships
- Identified issues, analyzed information and provided solutions to problems
- Actively listened to customers' requests, confirming full understanding before addressing concerns
- Prepared variety of different written communications, reports and documents
Team Lead & Pharmaceutical Assessor / Senior Expert
ICELANDIC MEDICINES AGENCY
Reykjavik
03.2007 - 03.2012
- Held full accountability for leading evaluation and assessment of ASMF and Module 3, for subsequent marketing authorization of new drug substances and products
- Attained marketing authorizations via national, MRP and DCP
- Provided scientific advice for EMA, focusing on evaluation of new clinical drug products and formulations
- Served as delegate at EMA joint CHMP/CVMP Quality Working Party and Biological Working Party and external expert at EDQM for Certification Division; evaluated DMFs for Certificate of Suitability of Ph.Eur.
Senior Advisor
MEDSAFE – NEW, MINISTRY OF HEALTH
Wellington
04.2010 - 12.2010
- Joined the organization on a one year secondment
- Provided interim leadership and advising on current affairs in the European regulatory status, including how Europe performs evaluations and methods to evaluate ASMF
- Gained understanding of bioequivalence assessment methods and knowledge of clinical related matters for generics
- Assessed several NCEs during tenure.
Lecturer
UNIVERSITY OF ICELAND
Reykjavik
01.2007 - 01.2010
- Delivered lectures across variety of departments, including pharmacy, continuing education, and chemistry
- Facilitated classroom discussion on drug design and discovery to fourth year pharmacy students across such topics as rational design, molecular modeling, and SAR
- Developed and delivered lectures on evaluation of European drug master files and using European Pharmacopoeia
- Supervised Analytical Chemistry Lab course for first year chemistry and biochemistry students, encompassing simple analytical methods and techniques; quantification of metals, acids, and bases; and use of instruments.
Research Associate, Drug Resistance Program
NATIONAL CANCER INSTITUTE
Frederick
06.2005 - 03.2007
- Directed development of antivirals effective against clinically relevant, drug resistant strains of HIV-1
- Oversaw initial drug testing, and molecular modeling, computation; designed synthetic pathways and synthesized designed molecules
- Characterized and purified designed molecules, including NMR, IR, UV/VIS, LCMS, and HPLC; designed cell- and enzyme-based in-vitro assays, using replication incompetent viral particles in cell-based assays designed with single cycle infection vector encoded with luciferase reporter for quantification
- Contributed to development of applications for use as tools in virology and lead compounds for further drug design.
Post Doctoral Research
INSTITUTE FOR STRUCTURAL BIOLOGY AND DRUG DISCOVERY
Richmond
06.2003 - 06.2005
- Awarded post-doctoral fellowship from American Heart Association to pursue development of novel antithrombin activators for factor Xa inhibition
- Focused on solving synthetic issues associated with small organic sulfates and establishing purification and characterization protocols for highly charged molecules, using LC/MS and GC/MS methods.
- Identified issues, analyzed information and provided solutions to problems
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Carried out day-to-day duties accurately and efficiently
Education
Ph.D. - Medicinal Chemistry
Virginia Commonwealth University
Richmond, Virginia, USA 08.1998 - 06.2003
Bachelor of Science - Biochemistry
UNIVERSITY oF ICELAND
Reykjavik, RKV 08.1994 - 06.1997
Certification
Continuing Education: UNIX Intermediate Training, Virginia Commonwealth University (2004); American Chemical Society Short Course, Capillary Electrophoresis (2003); NIH/NCI Short Courses, Catalyst Pharmacophore Generation (2006); Ph.Eur, The European Pharmacopoeia Training Session (2007); Assessors Training, Multivariate Data Analysis for QbD and NIR and Genotoxic Impurities (2008 - 2013), Numerous EMA and EDQM training courses (2012-2022) on guidelines, ICH, GMP and specific products
Timeline
Senior Pharmaceutical Assessor
ICELANDIC MEDICINES AGENCY
01.2020 - Current
Senior Pharmaceutical Assessor
DANISH MEDICINES AGENCY, LÆGEMIDDELSTYRELSEN
01.2016 - 06.2022
Program Scientific Officer
EUROPEAN DIRECTORATE, QUALITY OF MEDICINES AND HEALTHCARE
03.2012 - 01.2016
Senior Advisor
MEDSAFE – NEW, MINISTRY OF HEALTH
04.2010 - 12.2010
Team Lead & Pharmaceutical Assessor / Senior Expert
ICELANDIC MEDICINES AGENCY
03.2007 - 03.2012
Lecturer
UNIVERSITY OF ICELAND
01.2007 - 01.2010
Research Associate, Drug Resistance Program
NATIONAL CANCER INSTITUTE
06.2005 - 03.2007
Post Doctoral Research
INSTITUTE FOR STRUCTURAL BIOLOGY AND DRUG DISCOVERY
06.2003 - 06.2005
Ph.D. - Medicinal Chemistry
Virginia Commonwealth University
08.1998 - 06.2003
Bachelor of Science - Biochemistry
UNIVERSITY oF ICELAND
08.1994 - 06.1997
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