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Michael Swedberg

Michael D. B. Swedberg, Ph.D. served as an associate director at AstraZeneca R&D, Södertälje, Sweden, since 1996. Michael provides expertise in CNS in vivo pharmacology, abuse liability and safety pharmacology. He interacts and manages collaborative studies with CRO’s and academic laboratories world-wide, and with a wide contact net he is able to provide a wide range of study types in various locations and species. Michael has a long record of productive international collaborations with Big Pharma as well as smaller companies, in addition to living and working abroad for 11 years. Michael provides high quality writing and review of GLP and non-GLP study reports, pharmacological sections of nonclinical safety summaries (INDIMPD), Investigator Brochures (IB), and manuscripts for publication.

A highly motivated, dedicated and goal directed scientist, study director, project safety pharmacologist and manager, Michael was the supervisor of the Central Nervous System and Gastrointestinal section of the Safety Pharmacology Department at AstraZeneca R&D Södertälje, Sweden. The CNS and GI section was recognised as a highly productive and innovative laboratory within the company. Michael successfully devised and implemented a preclinical drug abuse and dependence liability assessment strategy and created an in-house GLP compliant Center of Expertise laboratory, fully equipped with state of the art technology to satisfy FDA and EMA regulatory requirements. Michael represented AstraZeneca in reviewing FDA and EMA regulatory guidelines in the drug abuse liability assessment area. Managing the CNS and GI Safety Pharmacology Section he was able to service projects at early and late stages with regulatory and non-regulatory studies. In addition to standard in vivo pharmacology models, he also initiated and supervised the development of novel behavioral models for assessing auditory and visual disturbances. As a people oriented line manager he directed and took managerial care of a group of highly dedicated academics and laboratory specialists. Michael has published in excess of 60 peer reviewed papers in world class scientific journals.

After his dissertation at the University of Uppsala in 1985, Michael started his career as a post-doctoral fellow with the National Institute on Drug Abuse, NIH, in Baltimore, MD, USA, and moved on to industry in 1988 to conduct drug discovery pharmacology as a senior research scientist and line manager at Ferrosan and NovoNordisk in Copenhagen, Denmark, and Astra Pain Control and AstraZenecaSödertälje, Sweden.

, , , , , , Behavioural pharmacology, Safety pharmacology, Drug Abuse Liability Assessment, Drug Dependence Liability Assessment, Drug discrimination, Drug self-administration, Behavioural models, Study Director, Good Laboratory Practice (GLP), Quality management, Quality assurance, Regulatory inspections, Regulatory documentation, Regulatory IND submissions, Risk assessment, Abuse Liability Assessment strategy, Investigational New Drug (INDIMPD) submissions, Investigational Brochures, Public presentations, Line management, People skills.