Spain Local Networking Group

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Introduce yourself!

  • 1.  Introduce yourself!

    Posted 02-Nov-2022 05:51
    Edited by Ryan Connors 02-Nov-2022 09:56

    Welcome to the RAPS Spain 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'll go first:

    I am Raquel Carnero, I am Senior SME at IQVIA Regulatory Intelligence for medical devices but I have more than 15 years experience in both pharma and medical device companies. I work for IQVIA A Regulatory Intelligence online database that provides access to regulatory requirements for Human Drugs & Biologics and Medical Devices & IVDs, for around 110 countries, regions and international organisations. online database that provides access to regulatory requirements for Human Drugs & Biologics and Medical Devices & IVDs, for around 110 countries, regions and international organisations.

    I am passionate about learning and sharing experiences and I hope this LNG will allow us to network and create a useful platform for other regulatory affairs colleagues.

    I can't wait to hear from all of you!


    ------------------------------
    RAQUEL CARNERO
    Madrid
    Spain
    ------------------------------


  • 2.  RE: Introduce yourself!

    Posted 02-Nov-2022 11:21

    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.



    ------------------------------
    Alexandra Rosa
    Oeiras-Lisboa
    Portugal
    ------------------------------



  • 3.  RE: Introduce yourself!

    Posted 05-Nov-2022 05:08
    Hello Everyone!

    I am also very happy for this new group. I have missed my regulatory colleagues and friends. I left Colorado 12 years ago and was very active with my local RAPS group as president, treasurer and continuing education lead for many years. My passion was holding 12 week sessions to prepare for the RAC exams. To have the answers so readily available after my first 10 years of strugglingand enduring a consent decree, I knew I needed to spread the word!

    I have been in quality and regulatory for 35 years focusing primarily on the IVD and medical device sectors. I love to see the new technologies and enjoy working with small start ups. I am an independent consultant for the past 25 years but in Europe I often contract through agencies as my network is radically different than the one I had in Colorado. I am currently doing quite a few ISO13485 audits and have projects on and off with some large companies (Pfizer, Abbott, Roche, Thermo Fisher). 

    I look forward to hearing what's happening and supporting this group in any way that I can!

    Saludos from the Costa Brava,

    Nanci Dexter
    RAC (US & EU)
    Recipient of the Leonard Stauffer award 2009 (RAPS)
    CQA, CQM/OE, CQIA
    ISO13485 Lead Auditor (BSI)







  • 4.  RE: Introduce yourself!

    Posted 03-Nov-2022 02:51

    Hello,

    I am Almudena Gómez, Qualified Person at Inves Biofarm, I have more than 15 years of experience in pharma, medical devices and cosmetics fields. I have developed my career in quality assurance and regulatory affairs. Inves Biofarm is an OEM that develops and produces medical devices for dermatological diseases, dermal fillers, eye drops, etc.

    I hope this LNG helps us to be connected with colleagues in the same situation so we could learn and share experiences.

    Thank you for your initiative.

    Almudena Gómez
    Granada
    Spain



    ------------------------------
    Almudena Gómez
    Granada
    Spain
    ------------------------------



  • 5.  RE: Introduce yourself!

    Posted 03-Nov-2022 14:36
    Hi everyone,

    Carlos Galamba here based out of Barcelona, but originally from Lisbon.

    I am a Vice President for Diagnostics at a large consulting firm RQM+. I currently sit in our Intelligence & Innovation division where regulatory intelligence plays a big part of our day to day. We also work with some of the largest medical device and IVD companies helping bring innovative products to market.  

    15+ years experience in IVDs and my previous role was with BSI leading the IVD technical Team of reviewers. Amongst many other things I spent the last few years helping BSI get designated to the IVDR and trying to figure out what it all meant! :) 

    I am also an external expert for the EU Commission advising on medtech policy and reviewing EU proposals.

    I look forward to connecting with other regulatory and technical experts in Spain and continue to advance the profession. I am passionate about traveling, getting to know new cultures and learning new languages. I'm an avid crossfit enthusiast also (when my back allows it!)

    ------------------------------
    Carlos Galamba
    ------------------------------



  • 6.  RE: Introduce yourself!

    Posted 03-Nov-2022 15:11

    Hello RAPS Spain LNG,

    My name is Pol Fort Grèbol and I am a Project Manager Regulatory Affairs at DePuy Synthes. I am currenty based in Barcelona.

    I have 8+ years of experience in medical devices mostly capital equipment and orthopedic implants. From my perspective, the regulatory affairs profession is a great way to establish connections with different cultures and is extremely exciting as it is continuously evolving.

    From this LNG, I would like to expand my network and share our experiences as a community of professionals!

    Kind regards,
    Pol



    ------------------------------
    Pol Fort Grèbol
    New Brunswick NJ
    United States
    ------------------------------



  • 7.  RE: Introduce yourself!

    Posted 03-Nov-2022 15:53
    Dear all 
    Congratulations for the initiative 

    My name is Xavier Canals-Riera and I am Director of Tecno-med Ingenieros. We are an ISO 13485 certified consulting company dedicated only to medical devices based in Barcelona and Madrid with more than 25 years of experience. 
    My background is in Telecommunications Engineering, with 5+ years as Technical Director of an electromedical company and 15 years as a Notified Body auditor. 
    I am Vice President of the SEEIC (Spanish Society of Clinical Engineers), member of the Spanish Standardization Committees UNE for Patient Safety, Quality - ISO 13485 and president of the electromedical equipment committee. 

    It is a pleasure to be able to communicate with everyone through this channel and I hope we can share experiences and synergies.

    ------------------------------
    Xavier Canals-Riera
    Director Tecno-med
    Barcelona Spain
    xcanals@tecno-med.es
    ------------------------------



  • 8.  RE: Introduce yourself!

    Posted 03-Nov-2022 16:09
    Hi everyone!

    I am Víctor, a Junior Regulatory Affairs/Quality Assurance Specialist with 2 years of experience. Currently, I am in an Active Pharmaceutical Ingredient manufacturing company with customers all over the world.

    I really enjoy learning every day new things about RA. I hope this LNG will help me learn more and expand my professional network too.

    Nice to meet you all!

    ------------------------------
    Víctor Fernández Pons
    Barcelona
    Spain
    ------------------------------



  • 9.  RE: Introduce yourself!

    Posted 04-Nov-2022 01:39
    Dear all:

    Thanks so much for starting this initiative and inviting me.

    My name is Lourdes Contreras. I am a Pharmacist and I have been working for more than 14 years at Janssen-Cilag.

    Nowadays, I am working as a Regulatory Scientist Associate Manager at EMEA RA Oncology/Haematology TA. In this new role I am having the opportunity to wop pre-submission regulatory activities and interactions, and in different regulatory procedures and activities for medicinal products, medical devices, combined products, and IVD, i.e., CTA, CIA, PIP, etc. So, every day is a challenge, and I love challenges. 

    Previous experience at Janssen was focused at LOC level, working in different departments (Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Quality) and different therapeutics areas [HIV, Hepatitis, and Immunology portfolio (psoriasis, psoriasis arthritis, Crohn´s disease, ulcerative colitis disease)].

    I enjoy knowing people, doing different things, and learning every day from others and with others. 

    So, this network is a good opportunity and a way to connect with you. 

    I am passionate about traveling, getting to know new cultures, and learning new languages. 

    In my free time, I like to spend time doing outdoor sports, such as hiking, climbing, and cycling. 

    I look forward to connecting with you.




    ------------------------------
    Lourdes Contreras del Moral
    Madrid
    Spain
    ------------------------------



  • 10.  RE: Introduce yourself!

    Posted 04-Nov-2022 04:40
    Hi everyone,
    My name is Claire Murphy. 

    I'm an Electrical Engineer and co-founder of Tecno-med Ingenieros, Barcelona. Tecno-med is a medical device regulatory affairs consultancy company in business since 1995. Since then, we have accompanied many projects, companies and QA/RA professionals through their CE marking journey under the MDD/IVDD regimes and are now immersed in MDR/IVDR transitions. 

    My scope of work is focused entirely on devices but, as others have already said, the variety is immense and with "perma-innovation". More recently, projects have become very much more clinical and in close contact with clinical researchers and innovation drivers.

    My day to day work is in managing MDR/IVDR projects, QMS audits (e.g. per 13485, MDSAP or 21 CFR 820), organizing and participating in specialist training sessions on device RA/QA topics and attending sector events (among others, Euroconvergence by RAPS ��)

    I'm an ASQ-CQA (Biomed) qualified auditor and more recently (in 2021) achieved RAC certification from RAPS. 

    I'm delighted at the initiative to create a Spanish RAPS group and definitely look forward to connecting with you all! Well done!!

    Best regards,
    Claire


    Claire M. Murphy

    Socio Consultor

    Tecno-med Ingenieros, SL - Consultores Productos Sanitarios / Medical Device Consultants
    Parque Tecnológico BCNord, C/ Marie Curie num.8,  E08042 - Barcelona

    Tel: +34932917739 +34932917740 +34935353944 Fax: +34932998532
    Spaces Retiro, C/ Alfonso XII num.62  E28014 - Madrid Tel: +34910767142


    Tecno-med Ingenieros C/Marie Curie 8, E08042-Barcelona
    http://www.tecno-med.es  tel. +34 932917739
    Si este correo no va dirigido a vd, por favor avísenos y destrúyalo. 
    Gracias y disculpe las molestias.
    If this mail is not addressed to you, please tell us and discard it. 
    Thank you and apologies for any inconvenience.  





  • 11.  RE: Introduce yourself!

    Posted 16-Nov-2022 03:23

    Hi everybody.

     

    My name is David Salvatierra

     

    I am the Quality Director of Leventon located close to Barcelona. My background is Chemistry, and I am in the Medical Device business for almost 30 years.

    I have experience in Quality Control, Quality Assurance, Regulatory Affairs (we sell in more than 60 countries included USA and MDSAP countries) and Clinical Area and processes as sterilization by EtO, injection, Pad printing, assembling or US welding.

     

    Regards,

    David

     

     

    David Salvatierra
    Quality Director

     

    leventon


    Ronda Can Margarit, 38

    Pol. Ind. Can Margarit

    08635 Sant Esteve Sesrovires
    Barcelona Spain

    Tel. +34 938176316

    Mobile +699421501
    leventon.es­­

     

     






  • 12.  RE: Introduce yourself!

    Posted 08-Nov-2022 12:54

    Hi Everyone,

     

    My name is Adrien Jolion, I am working at Reprints Desk. We are specialized in providing and managing scientific literature through our platform Article Galaxy.

     

    We also have a tool Curedatis " Intelligent Systematic Review Engine for Confident Regulatory Decision Making "

     

    Please feel free to contact me if you would see some interest.

     

    Best regards,

     

    Adrien JOLION  |  Country Leader (France, Benelux, Spain, Italy, Portugal, Israel)
    Research Solutions, Inc.  
    Telephone: + 34 744 643 248

    ajolion@reprintsdesk.com

    Book a Meeting

     

       

     

     

     






  • 13.  RE: Introduce yourself!

    Posted 08-Nov-2022 13:34

    Hi everyone,

    My name is Juan Ángel Gracia García and I'm the regulatory strategy director of ZURKO Research.

     

    ZURKO is a european CRO based in Madrid, with offices and labs also in New York, Barcelona and Albacete and over 300 partners worldwide. We have 15 years of experience at preclinical and clinical studies for cosmetics, biocides, food supplements and medical devices couple with a complete service of international regulatory support, which means a 360º degree service for the whole registration process in different markets (EU and non European).

     

    Our main expertise is on borderline products (cosmetics, medical devices, biocides & drugs), being a single point of contact thanks to our multidisciplinary team with regulatory experts, CRA, CTA, biostatistician, etc.

     

    It's nice to meet you all and is a pleasure to be part of this network!

     

    signature_1589763372

     

    Responsable: ZURKO RESEARCH SL; Finalidad: prestarle los servicios que nos ha solicitado, atender sus solicitudes de información y enviarle comunicaciones comerciales. Derechos: Tiene derecho a acceder, rectificar y suprimir los datos, así como otros derechos, indicados en la información adicional, que puede ejercer enviando un email a dpo@smart-informatica.es. Información adicional: Puede consultar información adicional y detallada sobre Protección de Datos en https://zurkoresearch.com/rgpd/ . Este mensaje y sus archivos adjuntos van dirigidos exclusivamente a su destinatario, pudiendo contener información confidencial sometida a secreto profesional. No está permitida su reproducción o distribución sin nuestra autorización expresa. Si usted no es el destinatario final por favor elimínelo e infórmenos por esta vía.

     






  • 14.  RE: Introduce yourself!

    Posted 04-Nov-2022 02:44

    Hi All,

     

    It is my pleasure to be part of this group.

     

    My name is Reine and I´ve been a Medical Device Regulatory professional for 6 years .

     

    At BMS we represent and distribute for over 25 Medical Device manufacturers in the EU, and U.S.A (mainly Blood Banking Equipment) we assist manufacturers with Global registrations requirements particularly in the MENA region.

     

    Thank you for this great initiative ! looking forward to connecting and growing as a part of this community.

     

     

    Best Regards

     

     

    Reine Karouta

    Global Regulatory Affairs Lead

     

    Tel: +34 91 431 78 71

    www.bmskgroup.com

     

    Disclaimer: This message and any attachment is intended only for the person to whom it is addressed and is confidential. If you have received this message in error, please notify the sender and delete it immediately. The use, disclosure and/or reproduction of the message may be unlawful.

     

    Privacy & Laws: Please note that your contact details are being treated according to the Spanish Data Protection Law (LOPD) and Services of Information Society Law (LSSI), being recorded by BIOTECHNOLOGY MEDICAL SERVICES K. EUROPE SL in order to send information about products, services and responding to queries. You have the right to access, rectify, cancel and object the LOPD and opt-out of any commercial communications by electronic means in compliance with art. 21.2 LSSI through the following address: general@bmskgroup.com .

     






  • 15.  RE: Introduce yourself!

    Posted 08-Nov-2022 12:47

    Hi Reine,

     

    This is Adrien from ReprintsDesk, we provide two tools, one for access to scientific literature "Article Galaxy" and one to manage the Medical Device report for go to market "Curedatis".

     

    Would you be interested to have a deeper demo ?

     

    Thanks,

     

    Adrien Jolion

     

    Adrien JOLION  |  Country Leader (France, Benelux, Spain, Italy, Portugal, Israel)
    Research Solutions, Inc.  
    Telephone: + 34 744 643 248

    ajolion@reprintsdesk.com

    Book a Meeting

     

       

     

     

     

     

     






  • 16.  RE: Introduce yourself!

    Posted 04-Nov-2022 02:45
    Reine Karouta - BMS would like to recall the message, "Re: Introduce yourself!".




  • 17.  RE: Introduce yourself!

    Posted 04-Nov-2022 03:28
    Hi everyone,
    Thank you so much for setting up this community!

    I'm Charlene Boumard, based out of Barcelona and originally from France.
    I've been working in the MedTech industry for 8 years for various very large US-based manufacturers, in Regulatory Affairs, Regulatory Compliance and Commercial Quality systems roles supporting affiliates in EMEA and Globally.
    I'm now Director of Regulatory Strategy for Europe at Veeva MedTech. Veeva is a software and business consulting providers supporting the life science industry in their digital transformation - looking at the total product lifecycle. 

    I'm passionate about international regulations and how policies are being established across the globe, so really fortunate to be a few working groups with MedTech Europe in that regard :) 
    I'm really looking forward to participate in this LNG to grow my professional network here in Spain (and BCN), and learn from my peers

    ------------------------------
    Charlene Boumard
    Barcelona
    Spain
    ------------------------------



  • 18.  RE: Introduce yourself!

    Posted 04-Nov-2022 04:53
    Hi all, I am a pharmacist with over 31 years pharmaceutical experience in the Regulatory Affairs & Clinical Operations Fields. I have been an Associate Director of a CRO for over 7 years. Provide a full range of Services and therapeutical areas, related to drugs, generics, medical devices, cosmetics, disinfectants, OTC, biological and alimmentary supplements. The main indications I have worked for in the past are Digestive, Dermatology, Transplantation, Stem cells in stroke, antitumoral, AIDS, HCV, Respiratory, Advanced Therapies and cell Therapies. I am currently seeking for new vacancies related to Regulatory Affairs & Clinical Operations either on a freelancer basis or on permanent basis.

    ------------------------------
    Pilar Corraliza Pérez Regulatory Affairs & Clinical Research Services
    Consultor Senior
    Madrid, Spain
    pilarcorralizap@gmail.com
    +34727787065
    ------------------------------



  • 19.  RE: Introduce yourself!

    Posted 04-Nov-2022 04:38
    Hi there!

    I'm Fernando, based in the South of Spain in Sevilla.

    I'm a biochemist by training and hold a PhD in Biomedical Research. Most of my career, I have been working in academia -and as such, have around 12 years of experience as an IVD user :) -, mainly in neuroscience and cancer research. This has allowed me to live in different cities around the world, like London and San Francisco, and work in amazing institutions such as UCL and UCSF.

    For the last 5 years, I have been working as a consultant, first assisting start-ups from the healthcare sector with the development and financing of their innovative medical devices and pharmacological therapies projects to bring them to the market. Now, I work as a Clinical Evaluation and Scientific expert at PRO-LIANCE, a dynamic German company supporting Medical Device manufacturers in all areas of Clinical Evaluation, Regulatory Affairs, Risk Management, and Quality Management for the European Market.

    See you around!


    ------------------------------
    Fernando Muñoz Lobato
    Sevilla
    Spain
    ------------------------------



  • 20.  RE: Introduce yourself!

    Posted 04-Nov-2022 05:04
    Hi all,

    I am Claudia Carbonell, a Biomedical Engineer by training and I have a Master in Health Economics and Pharamacoeconomics. 

    Currently I work as Quality and Regulatory Affairs Specialist in a start-up in Barcelona. Before that, I was based in London also working in a start-up at the Quality and Regulatory Affairs team. 

    I have +6 years of experience in Quality and Regulatory Affairs for medical devices and during the last three years I've been focused on Software as a Medical Devices.

    I'm very happy to be part of this group.

    Thanks,
    Claudia


    ------------------------------
    Claudia Carbonell
    Barcelona
    Spain
    ------------------------------



  • 21.  RE: Introduce yourself!

    Posted 07-Nov-2022 11:49
    Nice to meet you all,

    My name is Carles Prats, I'm a Biologist (toxicology), MBA (UPF, BSM),
    and RAPS (medical devices). I have been working in consultancy,
    innovation & entrepreneurship (regional innovation agency), R&D
    Project Manager at Laboratorios Esteve and as managing director at a
    research centre, always in Barcelona area.

    Since 2019 I have been working as Business Development Manager at
    Aarhus University & Arhus University Hospital (Denmark) helping
    researchers to promote (license or spin-out) their
    inventions/technologies (IP based projects) in the area of medical
    devices and drug discovery.

    For family reasons, we are looking to relocate back to Spain as soon
    as possible.

    Best regards
    -----------------------------------------------------------------------
    Carles Prats
    Aarhus & Barcelona





  • 22.  RE: Introduce yourself!

    Posted 04-Nov-2022 05:50
    Dear All, 

    My name is Pilar Pascual. I am a pharmacist with more than 15 years of experience in the regulatory field.

    I'm working for Tiare Consulting as Regulatory Affirs Manager. We provide several services in different areas drugs, medical devices, cosmetics or food supplement. I am focused on medical device now.

    Thank you very much for this initiative and I hope we can grow professionally all together.

    ------------------------------
    Pilar Pascual Inoges
    Pozuelo De Alarcón
    Spain
    ------------------------------



  • 23.  RE: Introduce yourself!

    Posted 04-Nov-2022 05:57
    I am Eoin McGrath, originally from Ireland but 20 years living in Barcelona. While not a regulatory professional as such, much of my time in Spain was spent working for the European Society for Blood and Marrow Transplantation leading their accreditation scheme and coordinating the society's interactions with European regulators via EMA and DG SANTÉ. 
    Since February 2022, I am the Executive Director of ICCBBA www.isbt128.org, the organisation behind the ISBT128 Standard for terminology, coding and labelling of Medical Products of Human Origin (SoHO in EU terminology) e.g., blood, cells, tissues, organs, medical devices containing human substances.
    I am hoping to learn from this group and look forward to contributing what I can.

    ------------------------------
    Eoin McGrath
    ------------------------------



  • 24.  RE: Introduce yourself!

    Posted 04-Nov-2022 06:56
    Hi everyone!

    Such a nice initiative!

    I'm Bernardo Plaza, an electronic engineer from Málaga who moved to Valencia 9 years ago to scale our medical device startup eKuore. We started from zero to having a few devices cleared in different countries and regulations, EUCE, FDA, Russia, Saudi Arabia, and several from South Asia. I was responsible for creating and maintaining the QMS and dealing with regulations to place into the market our devices.

    Now we are dealing with MDR as I guess many of you are. I hope we find a way to improve the process that is killing innovation in Europe due to uncertainty. I'm also interested in ML/AI and blockchain technologies applied to medical devices. I think there are a lot of opportunities and possibilities for applications and products. 

    Looking forward to connecting with you all.






    ------------------------------
    Bernardo Plaza
    Burjassot
    Spain
    ------------------------------



  • 25.  RE: Introduce yourself!

    Posted 04-Nov-2022 07:26
    Hello all,
    My name is Eugenia Garcia and I work as Technical Advisor Regulatory Submission Manager in Medpace. 
    I have a pharmacist degree and I have worked in CRO industry almost 21 years. During the last 10 years I have been focussed on Global Regulatory roles with the following responsibilities:

    ·         Provide regulatory submissions strategic advice and guidance Sponsor to facilitate clinical trial submissions compliance with appropriate regulations and requirements

    ·         Prepare and/or review clinical trial core trial documents for compliance with relevant guidelines/regulations and for trial suitability

    ·         Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

    Happy to be in this group. It seems that we are a multidisciplinar group where we will be able to learn from each other. 

    Best regards

    Eugenia









  • 26.  RE: Introduce yourself!

    Posted 04-Nov-2022 11:34
    Hi everyone
    It is an excellent initiative!
    My name is Airama Albisa, and I have spent the last 15 years innovating, developing, producing, and marketing new products and processes for the chemistry, food and biotechnology industries. I am equally comfortable working at a laboratory bench or managing and assuring the quality of chemical and biotech products.
    After 10 years working in R&D department, I have moved to the regulatory affairs department.
    I work at Farmhispania Group, mainly preparing CMC dossiers for active pharmaceutical ingredients (APIs). Also, I provide technical support to international clients regarding our products.
    Regards

    ------------------------------
    Airama Albisa Novo
    Regulatory Affairs specialist
    Zaragoza
    Spain
    ------------------------------



  • 27.  RE: Introduce yourself!

    Posted 04-Nov-2022 12:19

    Saludos a tod@s, 

    Es muy satisfactorio ver el grupo que se está creando.  

     

    Me llamo Goretty Alonso, y me comunico desde los EEUU donde he desarrollado una extensa experiencia en Biotecnología, Ingeniería Biomédica y Biosensores que incluye Desarrollo de Producto, desde la creación de una idea a su comercialización, pasando por la aprobación por sistemas globales de regulación de productos de salud.

     

    Originalmente de Burgos y licenciada por la UVA, vine a USA a completar estudios de graduado que han llevado a participar en proyectos fascinantes de innovación reflejados en publicaciones, patentes y productos con gran éxito en el mercado.

     

    Mi especialización empezó en Biomateriales con un conocimiento muy extenso en Química de Polímeros.  De ahí pase a trabajar en la industria con hidrogeles, acrilatos de silicona, micro fabricación en termoplásticos para diagnostico molecular y técnicas de DNA análisis.  De ahí llegue a ser miembro de RAP con responsabilidad en el proceso corporativo de Compliance & Regulatory Submissions en el mercado global.

     

    Mas recientemente estoy trabajando en tecnología de biosensores con conceptos de microelectrónica y materiales. Busco colaboraciones en estos campos con ideas de producto y a nivel de consejo corporativo.



    Goretty Alonso Amigo, Ph.D., EMBA

    Cell Phone +1 (669) 356 2950
    Spanish WhatsApp +34 662 36 77 35
    Skype +1(408) 641-3974








  • 28.  RE: Introduce yourself!

    Posted 05-Nov-2022 04:45
    Hola a todos!
    Muy contenta de ver que por fin tenemos un grupo local.  

    Mi nombre es Silvia Baldirá y soy Ingeniera Industrial y Biomédica basada en Barcelona y trabajando en Regulatory Affairs y Calidad desde hace 8 años.

    La empresa MEDTECH GLOBAL www. medtech-global.com  es la plataforma con la que he operado como consultora freelance o en colaboración con algún profesional experto del sector.

    Espero que este grupo resulte una herramienta muy útil para todos nosotros donde  poder compartir ideas y experiencias mutuas en este contexto regulatorio tan complejo y cambiante que tenemos. 

    Encantada de conoceros y  un gran abrazo a todos!
    Silvia Baldirá
    sbaldira@medtech-global.com



    ------------------------------
    Silvia Baldira -
    International Quality and Regulatory Affairs Consultant (Europe)
    Barcelona
    Spain
    ------------------------------



  • 29.  RE: Introduce yourself!

    Posted 16-Nov-2022 12:07
    Hola a todos!

    Un placer formar parte del grupo y conocer el background de los integrantes con nombre y apellido.

    Soy Abdessamad Ismaili, Master en Management e Ingeniero Industrial de vocacion, ubicado en Barcelona.

    Llevo +10 años trabajando en sectores regulados y tecnologia,tanto nacional como internacional. Actualmente desempeño rol como Consultor Senior en Lifesciences & Tech ayudando a clientes de Pharma, Biotech y Medical Device a implementar tecnologias tanto en sus procesos productivos y operativos (GMP,GLP,GCP) como en sus productos (SaMD) para EMA/FDA y mercados emergentes.

    No lo podemos negar, la tecnologia es un must en estas areas pero la validacion y cualificacion de dichos sistemas supone un quebradero de cabeza para la industria. En mi opinion, hay una solucion a dicho problema, un punto intermedio y pragmatico. Mi pasion es hacer mas facil e intuitivo para mis clientes el marco regulatorio y de garantia de calidad (QA) con los principios basados Computer Software Assurance y Quality by Design.

    Espero de este grupo conocer los retos de los compañer@s en QA/RA y compartir puntos de vista, lecciones aprendidas y experiencias.

    En mi tiempo libre me gusta interactuar con la comunidad de Linkedin con contenido y algunos memes :) 

    Para cualquier consulta o proyecto podeis conectar conmigo en linkedin.com/in/SoftQ o por mail (ai.najib09@gmail.com).

    Un saludo,

    Abdessamad Ismaili, Snr Consultant - Lifescience & Tech








  • 30.  RE: Introduce yourself!

    Posted 06-Nov-2022 11:53
    I'm Lilián Palma, and I currently work as a Clinical Affairs Specialist at Establishment Labs. Basically, I'm involved in all activities regarding our clinical operations (Clinical Evaluation Process and Clinical Investigation) outside the USA. I have three years of experience in the Medical Device field and a Post-graduate program diploma in Medical Devices. I'm really passionate about regulatory topics most related to clinical affairs. 

    It's a pleasure to be part of this network, and I hope we all can support each other. 

    Take care, 

    Lilián Palma López

    ------------------------------
    Lilián Palma López
    Barcelona
    Spain
    ------------------------------



  • 31.  RE: Introduce yourself!

    Posted 07-Nov-2022 03:32
    Edited by Paloma López-Guerrero 07-Nov-2022 06:03
    Hello everyone!

    Congratulations for this idea!
    I'm Paloma Lopez, I work at EpisKey Medical Consulting as a consultant. I have been working since 2018 as a consultant, helping medical device manufacturers to comply with MDR/IVDR, ISO 13485 requirements and to design clinical investigations according to AEMPS and ISO 14155 requirements.

    I am delighted to be part of this group, I hope to learn and share many things with you.

    ------------------------------
    Paloma López-Guerrero
    Madrid
    Spain
    ------------------------------



  • 32.  RE: Introduce yourself!

    Posted 07-Nov-2022 04:09
    Hello everyone!

    My name is Lucía Mourenza, a pharmacist with 5 years of experience in the Regulatory Affairs field of the Pharmaceutical Industry. I have recently joined Janssen-Cilag in August 2022 as Regulatory Affairs Expert, having previously developed my career in companies such as Gilead S.L.U. and Laboratorios Farmacéuticos ROVI S.A.
    The main indications I have worked for in the past and present are Oncology, Inflammation, Cardiovascular and Coagulation, Pulmonary Arterial Hypertension and Multiple Sclerosis, performing, in this 5 years, regulatory submissions for both clinical trials and product registrations and working on the creation and review of promotional and non-promotional materials.

    I am passionate about reading and music (I play the piano. I also love traveling and getting to know other cultures, enjoy art and learning new languages. 

    I look forward to connecting with you.

    ------------------------------
    Lucía Mourenza
    Madrid
    Spain
    ------------------------------



  • 33.  RE: Introduce yourself!

    Posted 07-Nov-2022 10:47
    Hello everyone!

    First of all, I would like to thank this initiative since I think that in Spain, it is not easy to find groups related to Regulation. 

    My name is Estíbaliz Peralta. I studied pharmacy and have worked in pharmacy for eight years.
    Two years ago, after completing a master`s degree, I changed to a biotechnology company dedicated to developing and manufacturing in vitro diagnostic products with human applications, where I`m currently working as a junior Regulatory Affairs Technician. 

    In this changing regulatory world, I am sure that we can learn from each other and share training information!

    Nice to meet you!


    ------------------------------
    Estibaliz Peralta Pérez
    Zaragoza
    Spain
    ------------------------------



  • 34.  RE: Introduce yourself!

    Posted 07-Nov-2022 11:46
    Edited by Maria Duguine 07-Nov-2022 11:47
    Hello everyone!

    My name is Ma. Agustina Duguine, PhD in Chemistry, with 16 years of experience in the Regulatory Affairs in Medical Devices.
    I work close with the US chamber and I act as EU Authorized Representative for Medical Devices. 

    I´m consultant, specialized in the MDD/MDR and IVDD/IVDR transition and in the United States market where I collaborate.

    I enjoy playing padel!
    I look forward to connecting with you.


    ------------------------------
    Maria Duguine
    PRRC - EC Rep
    Barcelona
    Spain
    ------------------------------



  • 35.  RE: Introduce yourself!

    Posted 09-Nov-2022 12:24
    Hello everybody

    My name is Resu Alloza and I am a CMC consultant, owner of ReAl CMC Consultancy. My company is based in the Leiden Bioscience Park, The Netherlands, although I am originally from Spain. I have more than 30 years of CMC experience including R&D, tech transfer, GMP manufacturing and regulatory. 

    I am looking forward to connect with other experts, participate in the group and extend my professional network. 

    Resu Alloza
    Owner & Founder
    ReAl CMC Consultancy
    resu.alloza@real-cmc.nl


    ------------------------------
    Resurreccion Alloza
    Pharmaceutical Consultant
    Leiderdorp
    Netherlands
    ------------------------------



  • 36.  RE: Introduce yourself!

    Posted 09-Nov-2022 13:27
    Hello everyone,

    Such a good initiative!!

    My name is óscar Álvarez, a junior regulatory affairs technician with 2 years of experience. I am currently working in a generic drug company that exports all over the world. Specifically, my work is linked to the FDA since I am dedicated to elaborate ANDAs for the commercialization of drugs in the USA.

    Nice to meet you all and looking forward to learning from all of you.

    ----------------------------------
    Óscar Álvarez Colmenero
    Madrid
    Spain






  • 37.  RE: Introduce yourself!

    Posted 10-Nov-2022 01:21
    Hi Everyone

    By way of introduction, I am Dianna, South African, with 30 plus years experience in RA with the majority of my experience focussed in the Emerging markets (LATAM, ASIA, MENA and Africa) but also EU to an extent (R&D, CMC, Biologicals, Generics,  LCM etc).  I currently reside and work in Germany since 8 years,  as Team Lead for EU, Latam Asia and MENA and now in the role of Global  Regulatory  Affairs  Innovation  Strategy Lead since April 2022.  I look forward to interfacing with all of you and sharing experiences.

    ------------------------------
    Dianna Schaal
    Global Regulatory Affairs Innovation Strategy Lead
    Böblingen
    Germany
    ------------------------------



  • 38.  RE: Introduce yourself!

    Posted 22-Nov-2022 09:27

    Hello everybody,

     

    I think this group is an excellent idea to share experience at the level of Spain country regulation.

     

    My name is Elena Morollón, RA Manager in Becton Dickinson, S.A having experience about manufacturer and distribution activities in Spain and Portugal.

     

    Kind regards

     

    Elena

     

     

    Más información sobre el compromiso de BD con Seguridad-del-Paciente/BD

     

    Descripción: <a href=image002.png@01D1495A.42268500">

     

    Elena MOROLLON
    Regulatory Affairs Manager, Iberia

    BD Medical, Medication Delivery Solution

     

    Camino Valdeoliva, s/n

    28750 San Agustin del Guadalix (Madrid)
    tel: +34 91 848 81 00 mobile: No Mobile

    email: elena.morollon@bd.com  website: www.bd.com

     

    Descripción: <a href=image003.png@01D1543E.6E141350">

     


    Becton Dickinson S.A.
    DOMICILIO SOCIAL: Camino de Valdeoliva, s/n.
    28750 San Agustin del Guadalix - MADRID- C.I.F.A-50140706
    Sociedad Unipersonal inscrita en el Registro Mercantil de Madrid,
    Tomo 2472, Libro 0, Folio 95, Hoja M-43244

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  • 39.  RE: Introduce yourself!

    Posted 16-Nov-2022 02:51
    Dear everyone,

    First of all, thank you very much for this great initiative!

    My name is Mercè Guerra and I am a Regulatory Affairs Manager at Alira Health, based in Barcelona.  I am working as a regulatory consultant focusing primarily on the IVD and medical device sectors both in the EU and US.

    Thanks again for this great initiatitve and looking forward to connecting with other regulatory and technical experts in Spain

    Best regards,
    Mercè


    ------------------------------
    Merce Alba
    Barcelona
    Spain
    ------------------------------



  • 40.  RE: Introduce yourself!

    Posted 16-Nov-2022 08:34
    Fantastic initiative! Many thanks for setting this up.

    My name is Carlos Gil and hold a LLM (Master in Laws) by Instituto de Empresa, Madrid. I live in Valencia and work in the legal department of CELESTICA, a multinational corporation headquarted in Toronto. Celestica offers leading services in design, manufacturing, hardware platform and supply chain solutions to the world's most innnovative companies. I negotiate the design, development and manufacturing agreements for medical devices with our healthtech customers.

    I am delighted to get to know you!

    ------------------------------
    Carlos Gil Guzmán
    Celestica
    Valencia (Spain)
    ------------------------------



  • 41.  RE: Introduce yourself!

    Posted 22-Nov-2022 11:30
    I am Joan Camps, a regulatory affairs professional focused in GMP consulting for pharma manufacturing plants design.

    With more than 20 years of experience in engineering and manufacturing companies (including machinery, automotive, aeronautical and oil&gas industries), nowadays I manage the regulatory affairs department of the company AIRPLAN, S.A., dedicated to worldwide turnkey solutions for pharmaceutical manufacturing companies. From conceptual engineering until its turnkey construction and commissioning, also for the needed proces equipment involved.

    I like to learn, share and apply my experience in order to face all wide range of problems and issues, by putting up accurate solutions.

    With best regards,


    ------------------------------
    Joan Camps
    Regulatory Affairs Manager
    Sant Fruitós De Bages
    Spain
    ------------------------------



  • 42.  RE: Introduce yourself!

    Posted 30-Nov-2022 07:30
    Hi everyone!

    My name is David Pérez and I am Principal Consultant at Parexel for CMC biologics. I've been in Parexel for almost 3 years and before joining Parexel I worked at the Spanish Medicine Agency as Quality/CMC assessor for Biological products and Advance Therapy products. I am a Biologist with a PhD. In Molecular Biology and extensive research experience in biochemistry, immunology, virology and infectious diseases. My regulatory expertise includes assessment of national CTAs/INDs, VHPs, MAAs/BLAs and variations/PAS for biological products and advanced therapy products for the European and US markets. I also have extensive regulatory experience as Quality/CMC expert for Scientific Advice with EMA and FDA. As a Principal Consultant at PAREXEL I work along with clients on interactions with regulatory authorities for any kind of applications throughout the product development process and provide strategic advice on EU and US registration procedures for biological and Advance Therapy products.

    I am very excited to join this community!

    Looking forward to hear from you all!
    Best,
    David

    ------------------------------
    David Perez
    Principal Consultant
    Madrid
    Spain
    ------------------------------



  • 43.  RE: Introduce yourself!

    Posted 30-Nov-2022 12:36
    Edited by Claudia Carbonell 30-Nov-2022 12:45
    Hi everyone,

    I would like to let you know that at Methinks AI, the company were I work, we are looking for a Senior Regulatory Specialist with experience in software as a medical device, who can help us prepare 510(k) Submissions for our products (software to assist clinicians in the detection of stroke). We are looking for a hands-on person who is passionate about Regulatory and Software. 

    This may not be the ideal place to write this message but we are struggling to find someone.

    I would really appreciate it if you could share this with anyone that could be a good fit and is looking for new challenging opportunities.

    Thanks in advance,
    Claudia

    ------------------------------
    Claudia Carbonell
    Barcelona
    Spain
    ------------------------------



  • 44.  RE: Introduce yourself!

    Posted 01-Dec-2022 15:13

    Hi everyone,

    I am Silvia de Andrés, Quality Regulatory Specialist and Person Responsible for Regulatory Compliance in Life Length, a laboratory leader in telomere and telomerase measurement and manufacturer of medical devices.

    I have 4+ years of experience in Regulatory Affairs and vigilance in the medical devices sector, as well as background in Quality Assurance.

    I hope for this group to help me connect with other colleagues and share our experience and knowledge.

    Kind regards,

    Silvia






  • 45.  RE: Introduce yourself!

    Posted 12-Dec-2022 03:04

    Hello everyone, 

    My name is Beatriz Almendros, a quality and regulatory affair professional related to medical devices. At IMF we design and develop software for clinical support processes. Currently I am involved in the MDR certification for our SAMD and in the maintenance and improvement of our quality system certified in ISO 13485, ISO 9001, ISO 14001 and UNE 166002.

     I look forward to connecting with new colleagues and to help each other.

     Best regards



    ------------------------------
    BeatrizAlmendros
    Valencia
    Spain
    ------------------------------



  • 46.  RE: Introduce yourself!

    Posted 09-Jan-2023 10:50
    Hi everyone,

    My name is Ascensión. I have a bachelor degree in Pharmacy and I´ve been working as a Quality&Regulatory manager in the IVD sector for the last 15 years. I´m also a spokesperson for IVD at the Spanish Pharmacy Industry Association (AEFI) placed in Madrid.

    I would like to congrats RAPS for creating this chat and giving us the opportunity to share our ideas and comments with other knowledgeable professionals.
    Looking forward to hearing from you soon.

    Best regards

    Ascen

    ------------------------------
    Ascensión Hernández
    Ms
    Madrid
    Spain
    ------------------------------



  • 47.  RE: Introduce yourself!

    Posted 27-Sep-2023 06:51
    Edited by Miguel Mehrgut 27-Sep-2023 06:51

    Nice to Meet you all!

    I recently joined the RAPS (Drugs) group (yay!) after passing my Certification Test this summer.

    My background, 5y abroad working as GMP Production Team leader for ATMPs . However, I decided to join the "RA way" in 2023 due to a common interest in the applicable regulatory requirement.

    I´m temporarily  working in Madrid as RA Officer, covering a Maternity Leave, for a company providing Regulatory Strategy & Technical Services,  therefore, I´m open to new opportunities. 

    My day-to-day consist in working my way with eCTDs, NeeS for drugs of use in humans as well as providing support for communicating MDDs, FSS, Promo/Non-promo materials, and registration of companies and their products according to the national regulation. I joined recently so my competences keep expanding, so far my experience in GMP has been of great interest for the preparation of protocols and such, so I´m very excited about my future in this field!

    You can contact me directly through here or LinkedIn if any of this is of your interest, 

    Regards,



    ------------------------------

    Miguel Mehrgut – MSc RAC

    Regulatory Affairs Officer

    Madrid (Spain)

    Member of regulanet®

    www.regulanet.com
    ------------------------------