Portugal Local Networking Group

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  • 1.  Introduce yourself!

    Posted 14-Dec-2022 06:00
    Welcome to the RAPS Portugal Local Networking Group (LNG)! Please introduce yourself. Tell us what makes you passionate about regulatory affairs, whether you’re a RAPS member, and what you’d like to get out of this LNG.

    I am Alexandra Rosa, a regulatory affairs professional with experience in R&D and teaching. At IQVIA, I’ve been involved in Divestments and currently I’m working in Pre-Submissions and Regulatory Strategy. Current projects I’m involved at include preparation of niche submissions such as PIP/PSP, ODD, PRIME, IP and preparation of scientific advice meetings (for instance with EMA, MHRA/NICE, FDA). I’m passionate about this segment of regulatory affairs as there is never a boring day and you can actually witness medicines going from the bench to the bedside! From this LNG I expect to grow my professional network, learn from other regulatory affairs professionals and, also, to share my experience.

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    Alexandra Rosa
    Oeiras-Lisboa
    Portugal
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  • 2.  RE: Introduce yourself!

    Posted 15-Dec-2022 05:34
    Hi everyone!
    I am Célia Cruz, Head of Regulatory Affairs at Complear. We are a consultancy company focused on supporting medical device software companies in regulatory and quality fields. I'm a biomedical engineer by training, and really excited to be in this field, supporting innovation to get to the market (even though with the changes that medical device software has been undergoing). 
    I look forward to connecting with other regulatory and technical experts, as well as learning and sharing within this network! 
    Looking forward to meeting you in our future activities!


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    Celia Cruz
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  • 3.  RE: Introduce yourself!

    Posted 15-Dec-2022 06:38

    Hello everyone!

     

    My name is Nádia Cantanhede, I'm a Regulatory Affairs Specialist at Hovione and I have been working in Regulatory Affairs for 13 years.

    I'm Clinical Psychologist by training but wanted to challenge myself in a different field and fell in love with Regulatory Affairs area.

    I have performed submissions of DMFs of APIs in several Competent Authorities but my main work is to provide technical support to our customers (other pharmaceutical companies).

    I'm very enthusiastic with this group and willing that we are all enhanced by this valuable experience of sharing knowledge and experience in our field.

     

    Best wishes,

    Nádia Cantanhede

    Regulatory Affairs Specialist

    Shared Services

    T. +351 219 829 240

    cantanhede@hovione.com www.hovione.com

    WARNING: This e-mail may contain confidential and/or privileged information. If you are not the

    intended recipient (or have received this e-mail in error) please notify the sender immediately and

    destroy this e-mail. Any unauthorized copying, disclosure or distribution of the material in this e-mail

    is strictly forbidden. This e-mail reflects the views of its author and not necessarily those of Hovione.

     






  • 4.  RE: Introduce yourself!

    Posted 22-Dec-2022 14:49
    Edited by Isabel Lopez 22-Dec-2022 14:49

    Hello everyone!

    My name is Isabel López, and I´m a regulatory affairs professional with more than 15 years of experience in the pharmaceutical and medical sector.  I´m currently working as CEO of Episkey Medical Consulting. Here, we carry projects that deal with obtaining the distribution licence for medical devices,  we help applying for the CE marking and we train our clients to act as Tecnical Responsible for their products. We are experts knowing exactly how to clasify medical devices according to the new regulations. 

    We love to see new projects and new technologies in our industry and to help interesting projects with the permits, authorisations, regulations and certifications that they need.

    Thanks for the initiative, I think this is a good way of sharing experiences, meet new colleagues and support each other!



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    Isabel Lopez
    Cascais - Lisboa
    Portugal
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  • 5.  RE: Introduce yourself!

    Posted 05-Jan-2023 06:41
    Edited by Sofia Montalvão 05-Jan-2023 06:41

    Hello!

    My name is Sofia Montalvão, I am a Regulatory Expert in chemical/healthcare/pharmaceutical sectors. I have been working in compliance for approx. 10 years.
    Previously, I have worked at the European Authorities (ECHA - European Chemicals Agency), industry (Kemira Oyj, Borealis AG) and intelligence provider (Chemical Watch). Currently, I am working in Solvay and based in Portugal.
    Academically, I have a M.Sc. in Biological Engineering (University of Minho, Portugal) and a Ph.D. in Pharmacology (University of Helsinki, Finland).

    I am an enthusiast on regulatory affairs - safety first!
    I am happy to be part of a dynamic role, from a product safety and business perspective - which involves a mix of science, law and business -, challenging on adaptability and strategic thinking skills, that are put to test every day, which is exciting.

    Thank you very much for creating this group - I am looking forward to network with other regulatory professionals and exchange views, experiences and ideas.



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    Sofia Montalvão
    Porto
    Portugal
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  • 6.  RE: Introduce yourself!

    Posted 07-Jan-2023 10:30
    Edited by Pedro Gameiro 07-Jan-2023 10:30
    Hello everyone!
    Hope the start of the year has been kind to all!

    My name is Pedro Gameiro and I work as a Life Sciences Consultant in Alten Portugal.
    I have recently accomplished 2 years in the Regulatory Affairs field and from the start I was captivated with this field and how broad it was!

    My start in this field was in Post-MAA activities with a focus in Portugal and Europe markets and I am now working with the EMEA region with a focus on pharmaceuticals.
    Pharmaceuticals Sciences is my background and, although I feel like my professional journey has only just begun, I see myself continuing to grow and thrive having seen how much there is to learn in the RA field and its intricacies - never a dull moment!
    I hope to hear from this community their different journeys, professional challenges and grow in this cooperative enviornment and knowledge pool.

    Looking forward to our future!



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    Pedro Gameiro
    RA Consultant
    Alten Portugal
    pedro.gameiro@alten.pt
    pedrogafc@gmail.com
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  • 7.  RE: Introduce yourself!

    Posted 12-Jan-2023 17:47
    Edited by Xavier Canals-Riera 12-Jan-2023 17:54
    Dear colleagues
    I am the Director of a consultancy based in Spain and we also work in Portugal where we have clients obtaining the CE marking and registering devices and manufacturers in the INFARMED databases.

    I encourage you to register also in the Spanish group
    Spain Local Networking Group 
    Best regards 

    Thank you for accepting me in your group where I hope to share experiences and common requirements.
    Obrigado por me aceitar em seu grupo onde espero compartilhar experiências e requisitos comuns.

    Xavier
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    Xavier Canals-Riera
    Director
    Tecno-med Ingenieros
    Medical Devices Consultants
    Barcelona Spain
    https://www.tecno-med.es
    xcanals@tecno-med.es
    +34 932917739
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  • 8.  RE: Introduce yourself!

    Posted 29-Jan-2023 07:12

     Hello everyone!

    I'm Susana Vidigal, a researcher in Centro de Biotecnologia e Química Fina (CBQF) of Escola Superior de Biotecnologia (ESB) of Universidade Católica Portuguesa (UCP). Currently, involved in the collaborative project between Amyris, a US Biotechnology company, and UCP – Alchemy Project -- for the valorisation of Amyris fermentation by-products with the development of new ingredients for food, animal feed, cosmetic and pharmaceutical applications. I apply my knowledge in biotechnology to contribute towards a more sustainable world.

    It is crucial for the long-term success of pharma and medtech industries to focus on sustainable production of devices and drugs. Regulators are more and more addressing environmental and sustainability topics during inspections. With my work I'll contribute to find solutions to these topics and to reduce the CO2 footprint of each of us.

    Looking forward to meeting you in our future activities!





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    Susana Vidigal
    Porto
    Portugal
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