Liliana Teles Email & Phone Number

Porto, Pt

Porto Area, Portugal

Critical Catalyst is a team of consultants experienced in regulatory affairs for the MEDICAL DEVICES, IN VITRO DIAGNOSTICS, DIGITAL HEALTH and COSMETICS industries.Regulatory affairs consulting company focused on Medical Device and In Vitro Diagnostics lifecycle compliance, including regulatory systems (EU, FDA), quality management systems (ISO 13485, ISO 9001, FDA QSR), risk management (ISO 14971, EN 62366), clinical evaluation, product safety and testing (IEC and ISO standards)… Show more Critical Catalyst is a team of consultants experienced in regulatory affairs for the MEDICAL DEVICES, IN VITRO DIAGNOSTICS, DIGITAL HEALTH and COSMETICS industries.Regulatory affairs consulting company focused on Medical Device and In Vitro Diagnostics lifecycle compliance, including regulatory systems (EU, FDA), quality management systems (ISO 13485, ISO 9001, FDA QSR), risk management (ISO 14971, EN 62366), clinical evaluation, product safety and testing (IEC and ISO standards), quality assurance and regulatory auditing. Show less

Post-Graduation in Clinical Investigation with Medicinal Products and Medical Devices- Fundamentals of Epidemiology, Preclinical Development, Clinical Development and Clinical Investigation- Regulatory Affairs and Ethics of Clinical Investigation, Regulatory Framework in Portugal and EU, MDR/IVDR requirements, Good Clinical Practice, Ethical principles, Post-Market Clinical Follow-Up. Regulatory Documentation for study application.- Clinical Investigation Planning, Clinical… Show more Post-Graduation in Clinical Investigation with Medicinal Products and Medical Devices- Fundamentals of Epidemiology, Preclinical Development, Clinical Development and Clinical Investigation- Regulatory Affairs and Ethics of Clinical Investigation, Regulatory Framework in Portugal and EU, MDR/IVDR requirements, Good Clinical Practice, Ethical principles, Post-Market Clinical Follow-Up. Regulatory Documentation for study application.- Clinical Investigation Planning, Clinical Development Plan for Medicines and Medical Devices, Essential documents, Operationalization, Stakeholders, Study Centers, Risk Management and Pharmacovigilance, Protection mechanisms and patents. Show less

Coimbra, Portugal

Regulatory Consultant & Training - Medical Device Quality Management System ISO 13485- Medical Device Good Distribution Practices- Regulatory framework applicable to Medical Devices- Risk Management according to EN ISO 14971- Transition from MDD to MDR and IVDR

Regulatory Affairs of Medical Devices and In Vitro DiagnosticsRegulatory Affairs of Cosmetic Products

Regulatory Affairs of Cosmetic Products

- Team management and supervision; - Representative at international meetings;- Hospital prescription checking and revision; - Patient care advisement and therapeutic monitoring;

- Team management and supervision- Co-responsible for the pharmacy’s compounding laboratory- Pharmacy’s general healthcare publications editor- Hospital prescription checking and revision - Patient care advisement and therapeutic monitoring

- Supervision of the union’s revenues and expenses management;- Oversight of the union’s executive board financial and patrimonial decisions.

- Educational politics and academic quality promotion among teaching institutions;- Promotion of sports practice and healthy life styles among the student community;- Coordination of projects and activities with cultural impact on the student community.

- Vice-President (2009)- Treasurer (2008)- Coordinator of Health Promotion and Education Department (2007)

Warsaw Area, Poland

Department of Drug TechnologyCollaboration on the synthesis and anticonvulsant activity assessment of novel 2,6-diketopiperazine derivatives.

Department of Organic ChemistryCollaboration on the synthesis of geranylated derivatives of baicalein by classic and microwave methodologies, purification and structural elucidation.

Department of Organic ChemistryCollaboration on the isolation of prenylated xantones of Garcinia merguensis by chromatography on silica gel and respective structural elucidation.

Master Of Science - Msc, Pharmaceutical Medicine

- Regulatory Affairs - Medical Device Development - Drug Research & Development - Pharmacovigilance - Healthcare Marketplace - Health.

Doctor Of Pharmacy - Pharmd, Msc Pharmaceutical Sciences

Postgraduate Course Of Update And Improvement In Medical Devices - From Concept To Market

- Innovation, Research and Development of Medical Devices - Regulatory Affairs - Quality and Audits on Medical Devices - SINATES and Legal.

Training Course On Safety Assessment Of Cosmetic Products In The European Union

- Cosmetics Legislation in the EU - Hazard, Risk, Risk Assessment and Risk Perception - Local toxicity : Skin & Eye irritation, Skin.

Advanced Course On Regulatory Affairs Of Medicines And Health Products

- Regulation in the drug life cycle - Regulation of medical devices and cosmetic products - Pharmacovigilance - Inspection, control.

Regulatory Affairs And Ethics Of Clinical Research

- Approval system for clinical studies involving human medicines, medical devices and other health products in Portugal and Europe.

Regulatory Affairs, Drug Safety And Pharmacovigilance

- European Regulation Systems; - Marketing Authorization Application Procedures and eCTD; - Post-cycle Management: Variations.

Design And Interpretation Of Clinical Trials

- Types of Clinical Trial Designs; - Randomization and Masking; - Outcomes and Analysis; - Ethics; - Reporting Results.

Epidemiology

- Experimental and Observational Study Designs; - Measures of Health Outcome Occurrence and Association; - Causality.