Fernanda Lima Oliveira Email and Phone Number

- Leadership of the e-Labeling project;- Leadership of the project to update the packaging materials in accordance with the new regulatory framework;- Support to the local and global team with CCP assessment;- Preparation of marketing authorization application and post-approval change application of small molecules and biologic products, and medical devices, in line with Brazilian requirements. - Participation in meetings with entities to discuss standards and public consultations;- Competitive intelligence;- Regulatory intelligence;- Regulatory support for pharmacovigilance activities and clinical trials of new molecules;- Technical support to local and global teams regarding Brazil's health requirements;- Support in inspections by local and international health authorities.

- Preparation of marketing authorization application and post-approval change application of small molecules and biologic products, and medical devices, in line with Brazilian requirements. - Responsible for legal documentation of manufacturing sites;- CCP assessment of post-registration changes and technical support to local teams and partners;- Participation in meetings with entities to discuss standards and public consultations;- Regulatory intelligence;- Evaluation of packaging and labeling to comply with current regulation;- Evaluation of promotional material;- Regulatory support to international partners to deal with products destined for export;- Feasibility assessment of new projects.

- Preparation of marketing authorization application and post-approval change application of small molecules and biologic products, and medical devices, in line with Brazilian requirements. - Technical support to local and global teams regarding Brazil's health requirements;- Support to the local and global team with CCP assessment;- Participation in meetings with entities to discuss standards and public consultations;- Updating the company's internal systems for control and traceability of submitted and planned processes, such as Veeva and TrackWise;- Evaluation of packaging and labeling to comply with current regulation;- Management of the issuance and sending of Pharmaceutical Product Certificates (CPP) – WHO model – for products intended for export.

- Preparation of marketing authorization application and post-approval change application of small molecules and biologic products, and medical devices, in line with Brazilian requirements. - Technical support to local and global teams regarding Brazil's health requirements;- Support to the local and global team with CCP assessment;- Participation in meetings with entities to discuss standards and public consultations;- Updating the company's internal systems for control and traceability of submitted and planned processes, such as Veeva and TrackWise;- Evaluation of packaging and labeling to comply with current regulation;- Management of the issuance and sending of Pharmaceutical Product Certificates (CPP) – WHO model – for products intended for export.

Monitoring the Official Diary of relevant matter, support to analysts in the preparation of marketing authorization petition and maintenance of drugs and medical devices registration, according to legislation, and review and approval of packaging material (labeling and package)

Microbiology Quality Control of BCG Vaccine - National Institute of Quality Control in HealthI have experience in quality control of BCG vaccine by Immunization National Program of Health Ministery, performancing assays for quality control of product, such as identification, dosing and termostability, besides the applicability and evaluation of alternative methods, development of control maps of results, review and development of SOPs and equipment and room temperature control.