The General Data Protection Regulation (GDPR), that became effective on 25th May 2018, introduced important changes regarding personal data. Along with the compliance with the requirements for the privacy of their own personnel and any clients, companies are also bound to evaluate in details how the new regulation affects each single process and activity, also in the regulatory affairs.
The regulatory world includes many sectors that can be affected by the regulation in force on the personal data processing, such as: pharmacovigilance, medical device vigilance, cosmetic vigilance, food vigilance, medical information, scientific information, meetings and congresses, quality, complaint management, etc.
In fact, personal data of clients and consumers, patients, health professionals, pharmaceutical sales representatives, congress lecturers, partners, suppliers and many others are often processed in the common regulatory practice.
Di Renzo Regulatory Affairs avails themselves of a lawyer and other personnel qualified in the treatment of personal data applied to regulatory affairs, with the aim of complying with the processing of personal data collected in the regulatory framework.
The services offered for the personal data processing are the following:
- Courses addressed to companies on the current regulations (Legislative Decree 196/2003 as amended, GDPR);
- Assistance in the evaluation of the GDPR impact on the company’s regulatory affairs;
- Drafting/revision of information on the privacy to be published on the company’s website;
- Drafting/revision of agreements for the appointment of the persons responsible of the data processing;
- Drafting/revision of Standard Operational Procedures (SOP) and relevant forms;
- Assistance in the evaluation and implementation of technical and organisational measures and their related documents;
- Revision of agreements with partners/suppliers/clients on the personal data processing.