Fatou Lô

Swiss regulatory submissions (Swissmedic), Product Lifecycle Management (submissions: CMC variations, artworks, labelling, Renewals a.o)

Sucessful RIMS project support (electronically published regulatory submission documents), Data Management, Data Migration

Sucessful Regulatory Product Lifecycle Management EU, CH, Asia, (Variations, PSURs, Renewals, license transfers, Artwork and Labelling Changes); Product responsibility for Fluad and Agrippal (influenza vaccines)

Roche Diagnostics Rotkreuz, Switzerland: Global Operations Study Department (Investigator Initiated Studies) Coordinating internal study protocol approval workflows for material support and grant payments Vifor Pharma Glattbrugg, Switzerland: Labelling Acino Pharma Aesch, Switzerland: RA Change control

Sucessful supervision of global variation projects for Abbott HQ Basel (EMEA, Middle East, Africa, APAC, LATAM countries). - in parallel Interims RA Management for Abbott Swiss Affiliate.

Position as single point of contact for Notifications of Clinical Trials conducted in Switzerland • Notification of clinical trials at the Healthcare Authority Swissmedic • Provide regulatory advice and guidance to Clinical Operations to ensure compliance with regulations and requirements • Create GCP expertise with focus on Switzerland as also on the basis of EU-ICH Guidelines

Contracted to fill role of RA Associate at Amgen Switzerland AG Position as single point of contact for Notifications of Clinical Trials conducted in Switzerland • Notification of clinical trials at the Healthcare Authority Swissmedic • Provide regulatory advice and guidance to Clinical Operations to ensure compliance with regulations and requirements • Create GCP expertise with focus on Switzerland as also on the basis of EU-ICH Guidelines

Planning, performing and monitoring all registration relevant applications for generic drug products

Diagnostic Test-Kit preventive care screening for genetic metabolic diseases on the request of PerkinElmer: Quantitative determination of clinically significant amino acids and acylcarnitines, detecting more than 30 different metabolic diseases using the MS/MS tandem mass spectrometer

Business Unit Bioanalytics (data analysis and QC) - Raw data quality control / presenting final results for sponsor reports for different bioanalytical pre-clinical study designs

Successful development of forensic-toxicological and pharmacological reference materials (calibrators, reference controls and standards), Sucessful implementation of external laboratory quality assessments. Lauched Products, Services: - Certified reference controls drugs of abuse, therapeutic drug monitoring - Proficiency test materials for international Quality Assurance Associations - Proficiency testing scheme development: Society for Toxicological and Forensic Chemistry (DE)

Responsibility for business unit Diagnostica: IVD manufacturing and QA - in-vitro diagnostica clinical chemistry - reference controls (toxicology and pharma): e.g. psychopharmaca, alcohol, Drugs of Abuse (hair, serum, saliva, whole blood, aquous)

Identification, classification, and characterization of microbiological species

Tissues sectioning, fixation, embedding, microtome cutting and staining, creation of immune-histochemical preparations, In-situ hybridization, autopsy assistance