André Garrido Email & Phone Number

Porto, Pt

R&D-Development | Medical Writer & Public Disclosure | Clinical Operations

R&D-Development | Clinical Operations

Business Consulting: Health Products; Regulatory Affairs; Clinical Studies; Medical Devices, Entity Licensing; Market Access; Pharmaceutical Marketing; Quality; Healthcare Products Surveillance; Research & Development; Training and Events

Global Regulatory Affairs, R&D Quality (Grq) | Data Transparency And Regulatory Disclosure

Porto E Região, Portugal

Responsible for quality, completeness, and archive of more than 140 TMF’s (paper & electronic systems) | Principal accountable for the Physical and Electronic Data Archiving of GCP, GLP and GVP files | Assisted line management with goals, plans, vendor selection, cost proposals, services contract negotiation and running, risk based plans, process improvement and resources for documental and databases management projects | Support TMF/eTMF activities for Clinical Trials (Phase I-IV) throughout the study | eCTD (electronic Common Technical Document) quality control (QC) & publishing for Clinical Studies Protocol & Reports for Marketing Authorizations (MA) submission packages and anonymization for Data Privacy (GDPR) | TMF/eTMF and Clinical Trial Transparency & Disclosure SME for FDA and EMA inspections & Senior documental inspection “War Room” manager | Teamwork with Clinical Operations Team, CROs (e.g. ICON/PRA Health Sciences, IQVIA, Parexel, Pharmanet, PPD, etc.) and worldwide research centers to obtain clinical trial documentation | Warranted regulatory compliance and Confidentiality-Integrity-Availability (CIA triad) of documental systems and procedures | Accountable for inspection readiness quality in documents/files & CDISC clinical databases specifications compliance for over more than 40 clinical studies (Phase I-IV) worldwide (Africa, Asia, Australia, Europe, North and South America Regions) | Clinical database CDISC global integration and harmonization project management (Phase I-IV trials) | Standard Operating Procedures (SOP’s) for archive/documental/data governance and clinical data transparency.

Porto

Technical, office and documental assistance | Archiving and follow-up of GxP Audit Reports and CAPA Plans.

Porto

Direct technical, office and documental assistance | Coordination with Legal Affairs and Purchase Section for Clinical Research services contract management | Cooperate with Clinical Research Team and CROs / research centers to obtain and for GCP/GDocP QC of clinical trial documentation.Organization, tracking and update of R&D research publications (pre-clinical and clinical) and bibliography research and maintenance (Endnote with several citations methods such as Neurology, APA)

Amarante, Porto, Portugal

Secondary level teacher of Integration Area.

London, England, United Kingdom

Elstree, England, United Kingdom

Burnham, England, United Kingdom

Penafiel, Porto, Portugal

Teacher of Citizenship & Environmental education

Vila Nova De Gaia

Audio transcription Specialist; Data treatment and text publishing.

Penafiel, Porto, Portugal

Inventory of legacy archive records for transfer to new facilities; Archive management and inventory of the "Casa da Companhia (Paço de Sousa)" historical and legacy archives.

Advanced Programme In Diplomacy, Institute For Political Studies Of Portuguese Catholic University

Duration and workload: 67,5 hours, from February 8 to March 11, 2022 | Credits 9 ECTS (European Credit Transfer and Accumulation System).

Executive Course In Project Management

Duration and workload: 52 hours, from February 4 to April 11, 2019 | Credits 15 ECTS (European Credit Transfer and Accumulation System).

Master In Art Studies - Theory And Criticism (Mfa), Faculty Of Fine Arts

Description: Writing and publishing about art | Cultural mediation | Collections management | Organization of exhibitions e other cultural.

Master In Arts - Medieval And Renaissance History (Ma), Faculty Of Arts

Description: Systematic and organized research of a vast range of themes and knowledge | High methodological preparation.

Bachelor Of Arts - In History (Ba), Faculty Of Arts

Develop academic research skills necessary to communication sciences, tourism, heritage management and preservation, public relations.

Languages And Literature: Portuguese-English (Attendance Only - Not Completed)