プロフィール詳細

プロジェクトを作成

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Dr. Giulia M.に依頼

Italy

Regulatory Affairs Consultant | Expert in CE marking, EU MDR 2017, CER - PMCF - PMS - PSUR Writing

プロフィール概要

I am pleased to introduce myself, I am Giulia, a pharmacist by background and I have 9+ years of experience in the regulatory field working for medical device (Abbott, Stryker) and pharmaceutical companies (Janssen, Fidia Farmaceutici). Over the years, I have gained experience in drafting technical files and all supporting documentation for medical devices (Class I, II and III, implantable and substance-based), obtaining certification by several notified bodies according to Directive 93/42 EEC, EU MDR. I provide daily strategic support in regulatory affairs, with a focus on product surveillance, such as the Clinical Evaluation Plan (CEP), the Clinical Evaluation Report (CER), the Postmarket Clinical Follow-up Plan and Report (PMCF), Periodic Safety Update Report (PSUR), Post Market Surveillance (PMS) for all classes of medical devices, for implantable and/or substance-based medical devices, in accordance with applicable European and non-EU destination country regulations (Regulation (EU) 2017/745, MDCG 2020-8, MEDDEV 2.7/1 (Revision 4), MDCG 2020-13, MDCG 2020-7, MDCG 2020-8 MDCG 2022-21) I also offer support in identifying the right classification of medical devices, providing literature-based rationale, preparation of artworks according to current regulations, General Safety and Performance Requirements Checklist /Essential requirements, and risk analysis according to ISO 14971. I look forward to discussing with you the positive contributions I could make as part of your project.

専門分野

• ☆ Pharmacy
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ CMC Documentation
• ☆ Medical Writing
• ☆ Medical Content Writing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription, General Proofreading & Editing, Translation

Research Gray Literature Search, Scientific and Technical Research

Consulting Regulatory Consulting

Product Development Formulation, Manufacturing, Quality Assurance & Control (QA/QC)

職務経験

Second University of Naples

- 現在

regulatory affairs manager

CROlife srl

3月 2022 - 現在

Technical Regulatory Associate

The Janssen Pharmaceutical Companies of Johnson & Johnson

5月 2020 - 2月 2022

Regulatory Compliance and Quality Assurance Specialist

Abbott Medical S.r.l.

7月 2019 - 5月 2020

RA/QA Specialist

Stryker srl

7月 2017 - 6月 2019

Regulatory Affairs Associate

Chemifarma S.p.A.

4月 2016 - 4月 2017

Partnership Policlinico Gemelli and Fidia Farmaceutici S.p.A.

Fellowship - Project in Regulatory Affairs

11月 2015 - 3月 2016

学歴

Postgraduate Master

Catholic University of the Sacred Heart, Rome

1月 2015 - 12月 2015

Master’s degree - Pharmacy and Industrial Pharmacy

Faculty of Pharmacy- Second University of Naples

10月 2007 - 3月 2014

Erasmus Project

Faculty of Pharmaceutical Sciences for Environment and Health, Villanueva de la Cañada, Madrid, Spain.

2月 2010 - 7月 2010

認定資格

• Advancing professional course in Medicines Development

  Pharmatrain - IFFAPP-SSFA Conference, Nobile Collegio Chimico Farmaceutico, Rome, Italy

  6月 2015 - 現在

• Basic training in Good Clinical Practice in Clinical Trials

  Policlinico Gemelli, Catholic university of the Sacred Heart, Rome, Italy

  5月 2015 - 現在

• Professional Qualification as Doctor of Pharmacy

  Faculty of Pharmacy- Second University of Naples

  7月 2014 - 現在