Helen Fornge

• To ensure that safety reporting is performed according to the relevant legislations, applicable SOPs, written procedures and agreements with the client; • To manage the overall safety-related activities in a clinical project in order to minimize possible risks related to its execution; • To guide, supervise and evaluate the performance of the Clinical Safety Associates.

• To ensure that the regulatory submissions are performed according to the relevant legislations, applicable SOPs, written procedures and agreements with the client; • To manage overall regulatory-related activities in clinical research, reimbursement and CE-marking projects; • To guide, supervise and evaluate the performance of the Regulatory Affairs Associates.

• Create and review of study specific procedures • Generation, Triaging and finalization of regulatory reports in safety database to ensure regulatory compliance • Safety regulatory reporting (expedited and periodic) to competent authorities, ethics committees and investigators as per required regulations and ensure all company, client, and regulatory timeframes are met.

Prepare, review and submit submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical study • Create, Review and approval of Master SIS/ICFs for compliance with SOPs, ICH/GCP and for consistency with the protocol. • Provide expertise on IP release requirements to project teams. • Train new team members

• Filing, Tracking, EC/Regulatory submission, Quality Control of TMF, Audit preparation, Payments and processing of invoices. • Coordinating logistics and shipment of study materials to sites • Co-monitoring with CRAs to ensure that the monitoring site files are always audit ready and site is inspection ready according to ICH GCP guidelines.