Pharmacovigilance

National/International Literature Search:

With our literature search system, PharmaSearch, we perform weekly/monthly/retrospective literature searches on our database which is kept up-to-date by periodical updates and you can access these search results by logging in with your username and your password on your special page.


Use of PharmaSoft Database (PharmaBase):

PharmaBase is a software that you can shape according to your needs with its secure archive, data recall, up-to-date Pharmacovigilance System Master File and alarm system features to comply with the electronic record book requirements of the Ministry of Health.  


Pharmacovigilance System Setup:

We build the pharmacovigilance system for you in accordance with current regulations and relevant guidelines covering your responsibility that you are obliged to fulfill.


Quality of a Pharmacovigilance System

We offer you customized solutions for execution of your responsibilities related to pharmacovigilance in accordance with quality requirements, correction and improvement of existing structures and processes.


Writing of In-House Pharmacovigilance Procedures (SOPs):

We write your standard operating procedures according to your wishes in applicable format that include your national and international pharmacovigilance responsibilities towards the relevant authorities.


Preparing Pharmacovigilance System Master File (PSMF):

In accordance with the current regulations and guidelines we prepare your Pharmacovigilance System Master File (PSMF) which is a living document that contains the details of all your pharmacovigilance system and we allow you to keep it up to date.


Preparing Risk Management Plan (RMP):

 We are writing for you the risk management plans for the cases to be presented during the license application and after authorization in line with the guideline Module VI – Guidance on Risk Management Systems dated June 24, 2015.


Preparing Periodic Benefit/Risk Evaluation Reports (PBRERs):

We track the dates of your PBRERs and we prepare your PBRERs in accordance with the guideline Module III-Periodic Benefit / Risk Evaluation Report dated September 10, 2014.


In-house Pharmacovigilance Trainings:

We carry out your in-house pharmacovigilance trainings in a format that covers your all employees in accordance with TUFAM’s requests.


Pre-audit consultancy/Mock audit:

Our expert staff performs a mock audit by transferring their experience to you to make you achieve a successful audit/inspection result.


Preparing/ Closing Corrective and Preventive Action Plan:

We help you to close your minor and major inspection findings from national and international authorities by preparing a corrective and preventive action plan.       

                 

Adverse Reaction Management:

  • Receiving, recording, MedDRA coding, medical assessment, follow-up actions and duplication control of adverse reactions from spontaneous reports and quality complaints.
  • Management of serious adverse reactions from clinical trials.
  • Reporting all local adverse reactions to global/licensor, if necessary.
  • Reporting all suspected serious adverse reactions to the authorities
  • Archiving of all adverse reactions
  • Following up and reflecting in PBRERs of all adverse reactions received from global/licensor and other countries
  • Management of Medical Queries
    • Management of medical queries from consumers/HCPs/represents, following up adverse reactions from medical queries and reflecting them in PBRERs
    • Management of medical queries received during non-working hours.


Follow-up Safety Warnings:

We follow up current safety warnings by performing daily screenings on TITCK, MHRA, EMA, FDA, TGA, Health Canada, Lareb, ANSM and BfArM web sites and unions/associations announcements.


Preparing Dear Healthcare Professional Letters - Dear Doctor Letters:

For you we prepare the Dear Doctor Letter which has to be prepared by the Marketing Authorization Holder after the approval of the Ministry of Health and has to be delivered directly to health care professionals. We offer solutions for the distribution and we help you to prepare the closing report.


Cosmetic Adverse Event Reporting:

On your behalf we fulfill your responsibility for the safety requirements of cosmetic products in accordance with Safety Assessment on Cosmetic Products Guide.


Preparing Medical Device Vigilance Reports:

On your behalf we fulfill your responsibility for the safety requirements of medical devices in accordance with Procedures and Principles Regarding Medical Device Alert Notification System, under the following headings.

  • Alert Tracking System services
    • Adverse events
    • Receipt of the report, following up to complete the missing parts
    • Assesment and ve decision about reporting
    • Reporting
    • Submission
    • Follow up
    • Reportings
    • Preparation of report for electronic submission on alert system
    • Manufacturer Adverse Event Reports
    • Field Safety Corrective Action Report
    • Field Safety Report Attachment
    • Preparation of dossiers
    • Submission to the Agency
    • Corrective actions
    • Planning
    • Consensus with the Ministry of Health
    • Information letter preparation/distribution
    • Execution


Crisis Management:

We manage the crisis scenario with our experienced team under the following topics.

Proactive management of the crisis.
Investigating the relationship of potential problem with the product in question, according to the investigation results if the problem is associated with the product, clarification of whether there is a problem due to the active substances, excipients or production method.
Taking the rapid action in order to prevent the conditions that would cause risk for public health, contacting with the Ministry of Health, if necessary ensuring the withdrawal of product from the market with accurate ratings.
Informing the public about the withdrawal in accordance with regulations, laws and company rules and finalization of the process after performing the necessary follow-up actions.
Taking the necessary corrective and preventive actions.