Pharma-Regist Kft. (Pharma-Regist, we, us) is a full-service Contract Research Organisation (CRO) certified according to ISO 9001:2015 standards, located in Budapest, Hungary. Pharma-Regist is committed to protecting the Personal Information of its employees, business partners, and other identifiable individuals. In this Policy, we clarify what information will be collected and how this data might be used. You can review, withdraw or update the personal data you provided to us anytime. We share your personal data only with your consent or as described in this Policy. Each employee has a personal responsibility to acquire and complies with this Policy. Your data will be handled by Pharma-Regist Kft. for more information about us please visit our Contact page on this website.
Personal Data Collection
When contacting us (via the website, phone, fax) we will handle your data according to the effective local legislation (Infotv. & EU GDPR).or e-mail), you provide personal information about yourself. This information is mandatory to be able to identify you. If you contact us we
Pharma-Regist must inform individuals, about the purpose the information will be collected and the third parties to which the personal data may be disclosed. All individual has the right to limit the use and disclosure of their personal information unless it is told in this policy in specific circumstances. Pharma-Regist must inform individuals and ask for permission in every case before their personal information would be used or disclosed for other purposes, then for which it was collected.
Types of Personal Data that Pharma-Regist collects, handles and processes
Partners: Pharma-Regist collects, handles, and stores relevant information on all its recent, former, and possible new partners. This information is given by the partners when contracting with Pharma-Regist and is handled in contracts and databases for contact, postal and invoicing purposes. No data is shared with third-party personnel unless on the request or the permission of the owner of the data.
Clinical information: as a CRO, we might collect, host and analyze health data related to clinical trials. In harmony with Good Clinical Practice (GCP) and the effective local law (GDPR, 2016/679 EU regulation, and effective local law, the Act XLVII of 1997, the Medical Data Act, and the Act CXII of 2011, Privacy Act), we do not collect and archive any personal data which are not anonymized before.
Health professionals' information: Pharma-Regist collects the CVs of medical doctors and health care providers in relation to clinical trials and we may use available contact information (e-mail address, phone numbers) to invite possible investigators to participate in a study. We do not use these data without the owner's specific permission for any different purposes than stated above.
Employee and human resource data: Pharma-Regist collects and stores personal information of applicants, employees, and contracted partners, including contact details, professional qualifications, previous employment history, etc. Furthermore, Pharma-Regist collects other personal data of its employees and contracted partners for performance measurement, payroll, and tax purposes. We may collect and forward the CVs of our employees or contracted partners to competent authorities in order to maintain legal procedures or to a recent or possible future partner (sponsor of a project, manufacturer of marketed products, etc.). Pharma-Regist collects and maintains, updates this information on a regular basis.
Pharmacovigilance: Pharma-Regist as a Marketing Authorization Holder (MAH) or to its MAH partners provides pre-and post-marketing pharmacovigilance activities. According to EU and local legislation (1235/2010/EC Regulation, 2010/84/EC Directive, Commission Implementing Regulation 520/2012, Act CLXXVI of 2011, 15/2012 EMMI Act, 52/2005 EüM Act, 35/2005 EüM Act, 235/2009 EüM Act, 137/2012 National Legal Act) Pharma-Regist must collect as much information as possible on a suspected drug-related adverse event, but at least the name of the reporter/identifier, the patient who had the symptoms (initials, age or date of birth, gender, ethnics, etc.) the name of the suspected drug, description of the adverse event. Contact details are also collected if follow-up is needed. This information must be forwarded to the responsible Qualified Person for Pharmacovigilance (QPPV).
For further information please see the relevant EU and local legislation or contact us.