Data Protection Services - EU GDPR Quality and IT Audits - Life Sciences US Privacy Shield - Legal Representative
Data Protection Services - EU GDPRQuality and IT Audits - Life SciencesUS Privacy Shield - Legal Representative 

For any question or for a quote, contact us at: contact@pharmarketing.net

Consulting on Data Protection, QA and IT

Dedicated to Life Sciences and Healthcare sectors

Europe, Middle-East and Africa

Member of the Board of Directors of Professional Associations DMB and ACDM

Member of AFAR, the French Regulatory Affairs Association

Member of AFCDP, the French Association of DPOs

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PharMarketing to speak at the German ePharma Day - Frankfurt - 5 June 2019

 

Topic of the conference: "From Patient-right to data protection: Germany moving forward. "

To view the agenda and book your seat: 

https://germanepharmaday2019.lsacademyevents.it/

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PharMarketing spoke at the Annual Conference of the Association for Clinical Data Management - Amsrdam - 11 & 12 March 2019

 

 

 

 

 

 

PharMarketing spoke on GDPR impacts for clinical research, and lessons learned.

150 clinical research professionals from all Europe and beyond attended this  conference.

 

To receive a copy of the presentation, send your professional email address to contact@pharmarketing.net  https://www.acdmconference.org/

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PharMarketing spoke at the Annual Conference of the Association Data Management Biomedical - Paris - 13 November 2018

 

 

PharMarketing spoke with its client, the French Biotech ABIVAX, on GDPR impacts for clinical research, and lessons learned.

 

220+ clinical research professionals from all France, Switzerland and Belgium  attended this  conference. T

 

o receive a copy of the presentation, send your professional email address to contact@pharmarketing.net  www.dmb-asso.org

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27/05/2018 - PharMarketing wins contract with UK CRO For Data Protection GDPR RGPD

 

This mid-size CRO is conducting Phase I/II trials accross UK, in its own clinics.

PharMarketing will act as a Data Protection Officer for all its personal data processes, including clinical trials activities and vigilance.

 

For any question on our consulting services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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30/03/2018 - PharMarketing wins contract with French CRO for Data Protection

 

PharMarketing will help this Professional Service company to become compliant with the new European Data Protection Law. (eugdpr.org) and local French variances from DPA CNIL and recently voted local French law. 

More details on the 'Data Protection' page.

 

For any question on our consulting services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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30/03/2018 - PharMarketing wins contract with French CRO for Data Protection GDPR RGPD

 

This Professional Services company based in France has been helping pharma laboratories in their Discovery, Clinical Development, Regulatory, and Market Access and Manufacturing for the past 20 years. Recognized as a strong and experienced partner by the industry, this trusted advisor has helped put several drugs on the market.

As part of its business, this CRO outsources most of the different activities to specialists, but still they do receive personal data from EU residents that fall under the GDPR European law. 

Also they want to use GDPR compliance as a new argument to maintain their clients' confidence, and as a marketing argument to win new prospects.

 

PharMarketing will help this Professional Service company to become compliant with the new European Data Protection Law. (eugdpr.org), but also local French variances from DPA CNIL and recently voted local French law. PharMarketing will also take into account the already existing numerous guidances in the pharmaceutical industry (GXP, ICH, CFR 21 Part 11, etc.).

 

For any question on our consulting services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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28/03/2018 - PharMarketing comments on French Parliament GDPR Law

 

Last Thursday, The French parliament adopted a 'localised' version of the EU GDPR regulation. Below you will find some comments / views of our team, in regards to our Pharma sector, especially Pharmacovigilance, Regulatory Affairs, Clinical and Observational Research. These comments will be updated on a regular basis, as the law evolves , or CNIL publishes new information, or we receive guidelines from regulatory bodies in EU.The full text of the French parliament can be accessed here: http://www.assemblee-nationale.fr/15/projets/pl0809.asp

 

For any question on our consulting services for healthcare and pharma companies, please contact us at contact@pharmarketing.net


Point clé dans le Projet de Loi adopté par le Sénat le 22 mars dernier: le secret médical sera opposable à la CNIL, en particulier concernant aux traitements de recherche médicale.  (article 4 alinéa 8, page 8)

 

Le Sénat français vient de préciser la loi (article 12 alinea 3) concernant les archives historiques en les excluant du droit de rectification: indication importante pour notre secteur de la recherche clinique et de la pharmacovigilance, qui rejoint des réflexions déjà entamées par @DMB - Data Management Biomédical et ACDM Conference : le patient pourra-t-il demander à ce que ses données soient retirées d'un essai clinique auquel il a participé ?

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26/03/2018 - PharMarketing wins contract with French Mid-Size Pharma Company

 

PharMarketing will help this well-known Pharma and Cosmetics Laboratory getting compliant with the new European Data Protection Law GDPR / RGPD (eugdpr.org), but also local French variances from DPA CNIL and recently voted local French data protection law. @PharMarketing will also take into account the already existing numerous guidances in the #pharmaceutical industry (GXP, ICH, CFR 21 Part 11, etc.).

 

With its HQ in France and several offices around the globe, this pharmaceutical company has been active for decades in developing and selling drugs, medical devices and cosmetics for improving patients' health and wellness.

 

PharMarketing will be working for this company-wide project with the following departments: HR, IT, Regulatory, Clinical Development, and more.

 

For any question on our consulting services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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09/03/2018 - PharMarketing delivers GDPR Training and Gap Analysis to a Healthcare Software Company

 

This European small startup software company is providing a very innovative portal to investigators within clinical trials, and has already several clients in the academic and pharma industry sectors in several countries.

 

Even if the personal data collected is anonymised, as per clinical research general guidelines (GCP), they are considered by European Data Protection Law GDPR law as 'Pseudonymised' and as such fall under the GDPR / RGPD law.

 

Pharmarketing, a division of SiliconMarketing, organised an interactive workshop to several people from the software company and one of its client. During this half day, PharMarketing identified the strengths of its client in regards to GDPR, but also the actions needed until 25 May 2018 and beyond. 

 

The key success factor was that PharMarketing personel have 15 years+experience in the 3 key fields for Data Protection and GDPR: IT systems and Data Management, Business Process Audit and Quality Assurance standards, and lastly with Clinical Research Business and industry regulations and guidelines.

 

The day after the workshop, PharMarketing sent a report identifying the tasks to do, with a workload estimate and a recommended planning.

 

PharMarketing will cintinue working for this company to provide Data Protection Officer services.

 

For any question on our consulting services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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13/02/2018 - PharMarketing wins contract with French Healthcare Software Company

 

PharMarketing will advise this mid size software company on the quality of their processes and IT systems. PharMarketing will deliver a GDPR interactive training, and perform a Gap Analysis.

 

For any question on our services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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23/01/2018 - PharMarketing delivers GDPR Training and Gap Analysis to a UK CRO

 

This mid-size CRO is headquartered in the UK with offices in the US. They provide services in Business Intelligence, Market Access. Observational Studies to their clients in Europe. 

 

Even if the personal data collected during observational studies is anonymised, and the National UK Healthcare Databases they use contain anonymised patient records also, as per clinical research general guidelines (GCP), they are considered by European Data Protection Law GDPR law as 'Pseudonymised' and as such fall under the GDPR / RGPD law.

 

Pharmarketing, a division of SiliconMarketing, organised an interactive workshop to 14 people from this fast growing CRO in January 2018 in London. During the day, PharMarketing identified the strengths of its client in regards to GDPR, but also the actions needed until 25 May 2018 and beyond. Several managers accross the companies' departments were interviewed, including the CEO, and an overall IT audit has been conducted.

 

The key success factor was that PharMarketing personel have 15 years+experience in the Pharma and Clinical Research sector, plus knowledge of what ICO (the UK Data Protection Agency) and the US Privacy Shield scheme require.

The day after the workshop, PharMarketing sent a report identifying the tasks to do, with a workload estimate and a recommended planning.

 

Since then, the UK CRO has started implementing themselves the most important points for the 25 May deadline. PharMarketing will continue working for this company to provide Data Protection Officer services.

 

For any question on our Data Protection or IT Audit consulting services for healthcare and pharma companies, contact us at contact@pharmarketing.net

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22/01/2018 - PharMarketing signs contract with European Data Management Service company

 

PharMarketing will advise this small data management company on the quality of their processes and IT systems. A GDPR training and Gap Aanalysis will be performed.

 

For any question on our services for pharma and CRO companies, contact us at contact@pharmarketing.net

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22/01/2018 - PharMarketing signs contract with European Data Management Service company

 

PharMarketing will advise this mid size service company on the quality of their processes and IT systems.

 

For any question on our services for pharma and CRO companies, contact us at contact@pharmarketing.net

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15/01/2018 - PharMarketing signs contract with UK CRO for GDPR Workshp and Gap Analysis

 

PharMarketing advised this mid size CRO on their data management processes, to streamline them, and stay compliant with industry guidelines and regulations. The perimeter emcompasses EU and the US as this Pharma service company has offices on both continents. The workshop and Gap Analysis were done in a few  days.

 

For any question on our services for pharma and CRO companies, contact us at contact@pharmarketing.net

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15/01/2018 - PharMarketing signs contract with UK CRO for Data Protection Compliance (GDPR / RGPD)

 

PharMarketing will advise this mid size CRO on their data management processes, to streamline them, and stay compliant with industry guidelines and regulations. The perimeter emcompasses EU and the US as this Pharma service company has offices on both continents.

 

For any question on our services for pharma and CRO companies, contact us at contact@pharmarketing.net

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06/11/2017 - PharMarketing attended ISPOR European Congress 2017 in Glasgow, UK

 

ISPOR stands for International Society for Pharmacoeconomics and Outcomes Research. Its annual european conference in Galsgow, UK 6 - 8 November, will gather around 8000 professionals working in observational and epidemiological studies, registries, and patients surveys. For more information, visit https://www.ispor.org/Event/index/2017Glasgow

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19/06/2017 - PharMarketing presented with its client Medsharing

 an oncology hybrid study run on eCRF EOL at DIA Annual Meeting in Chicago – 19-21 June 2017.

 

 

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14/03/2017 - PharMarketing spoke with its client Medsharing at the Association for Clinical Data Management (ACDM) Annual Conference on March 14th in Brussels on a medical device non interventional study in 10 countries.

 

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27/01/2017 - PharMarketing helped the Association of French Contract Research Organisations (AFCROs) to recruit participants for its annual conference in Paris.

 

The attendance jumped to 350+ this year. Bertrand Le Bourgeois from Silicon Marketing moderated workshop eHealth and Regulations, with 29 participants, and then summarised the proceedings in plenary session.

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01/02/2015 - PharMarketing supported 2nd European CROs Conference,  2-4 Feb 2015, Paris.

 

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