Spring Intro 2023

24/03/2023

The product and the trial from a safety perspective with the patient in focus • Values risks and weighs risk against benefit • Identifies trials that do not generate new information • Safety data (preclinical and human data) • Study design (relative to product and patients) • Choice of comparative treatment and doses • Quality (step by step, raw materials, manufacturing and durability) • Quality assurance (eg monitoring) • The study in relation to guidelines and regulations CTA- What does the SwedishMedicines Agency (MPA) review?

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What leads to questions fromMPAon the application?

• Deficiencies and uncertainties in, or incomplete application • Deficiencies or lack of risk / benefit evaluation • Inclusion and exclusion criteria • Failure to manage safety reporting • Dose of study drug or comparative drug • Failure in the statistical analysis • Labeling of study drugs

• GMP and manufacturing license • Deviations from the regulations

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