News & Events

The Adventure Continues for PharMarketing GDPR Life Sciences Data Protection, Data Privacy!


We are proud to announce the signing of our 88th client!


We would be thrilled to have you as one of our future partners. Contact us to explore the possibilities!


📩 contact@pharmarketing.net






23 July 2024

New consultant in our team!

We're thrilled to introduce our newest consultant, Valérie Isabelle!


We welcome Valérie with excitement to our team here in the Paris region. With her impressive background holding a Ph.D. in Biology, she brings a wealth of knowledge and expertise to our consultancy.



Learn more about Valérie by reading her biography


3 April 2024

35th anniversary of AFAR

PharMarketing was at the 35th Anniversary Party of the AFAR, the French Regulatory Affairs Association on 16 November 2023.

16 November 2023

World 3rd Fastest Computer Lauched Today in Finland


Breaking! 14 June 2022: World 3rd Fastest SuperComputer Launched Today in Finland. Executive Vice-President for a Europe fit for the Digital Age Margrethe Vestager said: Thanks to its massive computing capacity, Lumi will enable scientific breakthroughs in for instance medicine and climate research at a much faster pace. It could be in the development of vaccines, diagnosis of cancer, or mitigation of the effects of climate change.


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

CNIL : étude sur données de Géolocalisation collectées par applications mobiles


13 juin : La CNIL - Commission Nationale de l'Informatique et des Libertéslance une étude sur les données de géolocalisation collectées par des applications mobiles.


Comme annoncé dans son plan stratégique 2022-2024, la CNIL souhaite rendre visibles les flux de données des applications mobiles.

Le principal objectif de ce projet est de sensibiliser le public et les professionnels sur les enjeux liés à la collecte de données de géolocalisation par les applications mobiles. Un projet qui durera 15 mois à l’issue desquels les données seront supprimées.


Pour plus d'informations sur cet article, veuillez consulter ce lien :

https://lnkd.in/eBUBAifY


Pour plus d'informations sur les dernières actualités, inscrivez-vous à notre newsletter en nous contactant à l'adresse: contact (at) pharmarketing.net

EDPB to Discuss tomorrow on Personal Data Transfers to Russia


Breaking: European Data Protection Board EDPB to Discuss tomorrow on PersonalData Transfers to Russia. Wait for infos in the next days. See agenda here :


For more information on this article, please consult this link:

https://lnkd.in/eakFVv4f


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

13 June : the UK Health Research Authority HRA has launched a public conversation


Today 13 June the UK Health Research Authority HRA has launched a public conversation about how research ethics review could be changed to make it better for researchers, ethics committee members and people taking part in research. Complete the survey now (until 23 September)!


For more information on this article, please consult this link:

https://lnkd.in/eex-gM3v


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

Fiscalité Pharma : La France dernière en Europe


Étude PWC Leem : Fiscalité comparée des entreprises du médicament en France et en Europe : une nouvelle fois la France en dernière position des pays européens en matière de politique fiscale


GDPR USA Maryland: the Personal Information Protection Act (PIPA)


GDPR USA Maryland: the Personal Information Protection Act (PIPA), was enacted to make sure that Maryland consumers' personal identifying information is reasonably protected, and if it is compromised, they are notified so that they can take steps to protect themselves.


As the crime of identity theft has grown, lawmakers have worked to protect consumers' personal information from identity thieves. The Personal Information Protection Act (PIPA), Md. Code Ann. Com​m. Law 14-3504​, was enacted to make sure that Maryland consumers' personal identifying information is reasonably protected, and if it is compromised, they are notified so that they can take steps to protect themselves. PIPA contains provisions for notification of consumers in the event of a data security breach and for reasonable security measures to protect consumers' personal identifying information.


For more information on this article, please consult this link:

https://lnkd.in/efASaZEA


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

GDPR Google Analytics


GDPR Google Analytics peut-être utilisé si un serveur Proxy est correctement mis en place, et que les informations envoyées à Google sont Pseudonymisées. 


For more information on this article, please consult this link:

https://lnkd.in/e6KQphdN


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

GDPR Google Analytics


GDPR Google Analytics Can be Used if a Proxy Server is correctly Set up, @CNIL says, so that the information sent to Google is Pseudonymised.


For more information on this article, please consult this link:

https://lnkd.in/e6KQphdN


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

European Commission ’s MDCG


European Commission ’s MDCG clarifies IVDR requirements for using medical tests in clinical trials 

https://lnkd.in/eqT2tw-7  Medical Device Coordination Group


GDPR 8 and 9 June: 1st Regulatory Dialogue EU


GDPR 8 and 9 June: 1st Regulatory Dialogue EU - Western Balkans on Information Society and Media - "The need to prioritise … Free Flow of Data was highlighted" 


A core objective of the European Union’s engagement with the Western Balkans is to prepare them to meet all the requirements of membership. 

During the first day of the Dialogue, discussions focused on the European Electronic Communications Code, the Broadband Cost Reduction Directive, and developments in 5G, The EU Cybersecurity Act, the Network and Information Society Directive and the 5G toolbox. On the second day, panelists had an interactive session on the Digital Services Act and Digital Market Act, the Data Governance and Data Act and on European digital identity.


For more information on this article, please consult this link:

https://lnkd.in/e3j8Eqda


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

EU Data Governance Act Published in Official Journal - 16 May 2022


16 May 2022: EU Data Governance Act Published in Official Journal.


After the European Parliament, the Council today approved a new law to promote the availability of data and build a trustworthy environment.


The Data Governance Act will create a mechanism to enable the safe reuse of certain categories of public-sector data that are subject to the rights of others.


The DGA creates safeguards for public-sector data, data intermediation services and data altruism organisations against unlawful international transfer of or governmental access to non-personal data. For personal data, the EU already has similar safeguards under the GDPR.

The Commission may also adopt model contractual clauses to support public-sector bodies and re-users in the case of transfers of non-personal data covered by the DGA to third countries.


Read more in the next FREE PharMarketing GDPR Life Sciences monthly #Newsletter.


For more information on the latest news, subscribe to our newsletter by contacting us at contact (at) pharmarketing.net

PharMarketing GDPR Life Sciences to give an Online training at Fleming Conferences - 12 - 14 April 2021

Subject of the training: "Data Privacy & Data Integrity in Clinical Trials"

Dates and times: 12 - 14 April 2021 8:30 – 12:30 CEST (Central European Summer Time)

See agenda and register to the training here.

More information: contact (at) pharmarketing.net


PharMarketing GDPR Life Sciences signs its first client in Africa!

PharMarketing GDPR Life Sciences signs its first client in Africa!

PharMarketing GDPR Life Sciences, member of France Biotech and of the UK BIA, a consulting firm specializing in RGPD and GxP compliance, has just signed its first client in Africa: it is CRO Tecro Research, specialized in biometrics for medical research (http: / /tecro-research.com/), based in South Africa.
Tecro was created in 2016 and has around ten employees with experience in clinical data management and biostatistics. As Tecro started to manage clinical databases for trials recruiting in Europe, the CRO had to comply with the GDPR and have a legal representative in the EU and in the UK. These are the services that PharMarketing will deliver for Tecro in a few days deadline.

After Europe, America and Asia, PharMarketing now has clients based in 4 continents.

More information: contact (at) pharmarketing.net

PharMarketing GDPR Life Sciences signe son premier client en Afrique ! 

PharMarketing GDPR Life Sciences, membre de France Biotech et cabinet de conseil spécialisé en conformité RGPD et GxP, vient de signer son premier client en Afrique : il s’agit de la CRO Tecro Research , spécialisée en biométrie pour la recherche médicale (http://tecro-research.com/). , basée en Afrique du Sud. 
Tecro a été créée en 2016 et a une dizaine d’employés expérimentés en data management clinique et en biostatistiques. Tecro gérant des bases de données cliniques pour des essais recrutant en Europe, la CRO devait se mettre en conformité au RGPD et avoir un représentant légal en UE et en UK. C’est la mission que PharMarketing assurera pour Tecro en quelques jours. 

Après l'Europe, l'Amérique et l'Asie, PharMarketing a maintenant des clients basés dans 4 continents.
Plus d’informations : contact (at ) pharmarketing.net


The Dec20 / Jan21 Free Newsletter @PharMarketing GDPR Life Sciences will be issued shortly! 

All the lastest news on the post Brexit transition period and International Transfers.

To receive it, contact us at contact(at)pharmarketing.net
MabDesign the French Immunotherapy Network publishes an announcement on PharMarketing

19 May 2020 - MabDesign is the French network of biotechs dedicated to oncology and Car-T. Today, MabDesign published an announcement of PharMarketing, a member of this network.

Read more on MabDesign here.
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) publishes guidelines for Digital Health applications

7 May 2020 - Following the Digital Care Act (DVG) and Digital Health Applications Ordinance (DiGAV) of Dec 2019, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) published today guidelines for #DigitalHealth applications. The BfArM procedure is designed as a "Fast Track": The evaluation time for the BfArM is three months after receipt of the complete application.  
A DiGA is a medical device that has the properties described ion the BfArM website.
Digital health applications ( DiGA ) open up a wide range of possibilities to support in the detection and treatment of diseases and on the way to a self-determined healthy lifestyle. DiGA are thus "digital helpers" in the hands of the patient.

With its guide, the BfArM provides a summary of the regulations that can be found at various points in SGB V, in the DiGAV and in the annexes to the DiGAV. Applications for inclusion in the directory are made exclusively electronically via an application portal.
73 million patients can be prescribed DiGA care and will be reimbursed. read more

read more on BfArM page here.

To keep abreast of all news, subscribe to our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net
Coronavirus: European Commission issues guidance to mitigate Clinical Trials disruption in the EU

28 April 2020 - Coronavirus: European Commission issues guidance to mitigate #clinicaltrials disruption in the EU: 

3 key points: 
1) Distribution of medicines to patients, 
2) Remote source data verification (SDV), 
3) Communication to authorities (on patient safety).

Download guidance here.

To receive our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net
EDPB response to the US on the transfer of personal data for Scientific Research to combat COVID-19

24 April 2020 - Mark W. Libby Chargé d’Affaires, a.i United States Mission to the European Union, had asked the EDP aon the transfer of personal data for the purpose of scientific research and the development of vaccines and treatments to combat COVID-19.
The EDPB replied that Guidelines 03/2020, in particular Section 7 on international data transfers provide the framework for such transfers.
The EDPB tackled this topic in detail in its recently adopted guidelines (03/2020) on the processing of health data for scientific research. In its letter, the EDPB reiterates that the GDPR allows for collaboration between EEA and non-EEA scientists in the search for vaccines and treatments against COVID-19, while simultaneously protecting fundamental data protection rights in the EEA. 

When data are transferred outside of the EEA, solutions that guarantee the continuous protection of data subjects’ fundamental rights, such as adequacy decisions or appropriate safeguards (included in Article 46 GDPR) should be favoured, according to the EDPB. 
However, the EDPB considers that the fight against COVID-19 has been recognised by the EU and Member States as an important public interest, as it has caused an exceptional sanitary crisis of an unprecedented nature and scale. This may require urgent action in the field of scientific research, necessitating transfers of personal data to third countries or international organisations. 
In the absence of an adequacy decision or appropriate safeguards, public authorities and private entities may also rely upon derogations included in Article 49 GDPR

Access article here.

To receive our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net



French Magazine Pharmaceutiques publicised the nomination of the Founder of PharMarketing as President of French Medical Professionals Association AMMIS (ammis.assoconnect.com). Published in the issue N°276 of April 2020.


More information on AMMIS:

https://ammis.assoconnect.com/page/295108-prochaines-reunions


http://www.pharmaceutiques.com/
PharMarketing GDPR Life Sciences  to be part of #PartneringAgainstCOVID19

23 April 2020 - PharMarketing GDPR Life Sciences is proud to help with #Compliance, #GDPR and EU #Legal representation in #clinicaltrials and in #COVID19 projects. We are glad to be part of #PartneringAgainstCOVID19 to discuss new projects and pipelines in this field. We hope we meet you there. For immediate assistance, please contact us at contact(at)pharmarketing.net or via our website https://login.inova-event.com/inova-business-platform/webclient/#/bio

To receive our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net
EMA published notice on Validation and Qualification of Computer System used in Clinical Trials

17 April 2020 - Given recent inspection findings and the implications they have had on the integrity, reliability, robustness and acceptability of data in the context of MAAs, the GCP Inspectors Working Group (IWG) in cooperation with the Committee for Medicinal Products for Human Use (CHMP) sees the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial data.
Findings:

  •     Lack of documentation (or access to documentation) of qualification activities
  •     Insufficient contractual arrangements

Conclusion of EMA: If appropriate contracts cannot be put in place, e.g. because a vendor does not allow provision of adequate measures as listed above (access to system requirements specifications, prequalification audits, access for GCP inspectors, etc.) and set out in Q&A # 8, systems from such a vendor shall not be used in clinical trials.


To receive our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net
The French CNIL publishes New HR Guidance Document - Organisations will need to do a Gap Analysis between their HR processes and these Guidelines and re-certify to the CNIL

15 April 2020 - CNIL, the French Data Protection Authority, issued its new HR guidance document.
It replaces the NS46 'Simplified Norm' (or 'Norme Simplifiée), which was not valid anymore since GDPR came into force on May 2018 anyway.
Let's remind that all authorisation procedures from the CNIL from before May 2018 are valid only for 3 years after an organisation sent a compliance declaration to the CNIL.
If the business process is still the same (e.g.employee appraisals, payroll software, electronic badges system, , etc.), then it's ok.
But it is very rare that an organisation will keep the business processes exactly the same for more than 3 years.
In that case, organisations need to document in their GDPR documentations the changes incurred sinces they made the compliance declaration to the CNIL, or , if the CNIL issued a new guidance document (for example for the vigilances), the organisation should again send a compliance declaration to the CNIL.

Feel free to contact us for more details via contact(at)pharmarketing.net, as we are regularly in touch with the lawyers of the French Data Protection Authority.
 
Key takeaways from the new HR Guidance document:
The new Guidance document applies to both public (= Government owned) and private organisations.
It doesn't include specific processes that are already subject to specific rules and guidances such as:
  •     Access control to work premises with biometry systems,
  •     Whistle blowers inside professional work,
  •     CCTV,
  •     Listening and recording of phone calls,
  •     Algorithms to predict the behavior or productivity of employees,
  •     Invasive processes,
  •     Processes using innovative new technologies.

Compared to NS46, the perimeter is larger, because it includes also payroll and key recruitment processes. The new document details the legal basis that can be used for the different processings. It provides also more information to understand when a DPIA should be drafted for a given HR process.


To receive our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net
Greece: 5000 Euros fine on Speech Therapy Center for Not Complying with Parents' access to Minor Child Information

20 March 2020 - The Greek DPA imposed a fine of 5000 Euros on Toyfas, a Speech therapy Center for children ((Κέντρο Λογοθεραπείας) because 
  1. did not satisfy it parental right of access exercising the parental care in the data of the minor of his child and
  2. did not comply with relevant recommendation of the Authority. Specifically, the Center did not grant the father who had parental responsibility upon request laccess to the last sessions speech therapy to which his minor child was subjected.
The father also wanted to have access to tax documents where the child's name was mentioned.
The denial of the Center was due, in particular, to the lack of consent of the mother, but then the Greek DPA stated that the Center should satisfy the right of the father, but the Center continued to refuse.
The Authority ruled out that it did not exist a valid reason for restricting the right of the father to access the requested information.

To receive our GDPR Life Sciences free Newsletter write to contact (at) pharmarketing.net
German Infection Protection Act will reduce Data Privacy Protection, BfDI warns

23 March 2020 - In view of the Corona crisis, the Infection Protection Act should be quickly adapted to the new situation. In the version now approved by the Federal Cabinet, restrictions on the fundamental right to data protection are planned: for example, the news version does not plan the deletion of data that are collected from travelers; also, the text doesn't include rules and safeguards for collecting data from mobile devices.
To receive the Newsletter write to contact@pharmarketing.net
French Pharma Laboratoires Genevrier wants to access Identifiable Patient Data from Pegase Study; Paris Court to decide on 5 March

25 February 2020 - In 2008, French Healthcare Authority HAS evaluated the Chondrosulf,as not enough beneficial to patients. Chondrosulf, one of the key drugs sold by Laboratoires Genevrier., targets symptomatic slow-acting anti-arthritis.  The HAS asked Genevrier and other pharma companies producing similar drugs to conduct an observational study to further confirm the benefits of the drug. This study was conducted by CRO Laser in 2010. Following that study, the HAS decided not to pay anymore for the Chondrosulf and similar drugs. 8 drugs are affected by the opinion of the Transparency Commission, see here. Genevrier then asked Laser to provide the identifiable patient data from the Pegase study, which Laser refused to do. In 2019, Paris Commercial Court decided in favor of Genevrier, a decision Laser appealed.The final decision of the Court is expected on 5 March 2020.This will be a key decision in the light of GDPR and GCP, and patient privacy in general.
Read article(in French)