Ottosen Drug Safety and Pharmacovigilance



  • Qualified Person for PharmacoVigilance (QPPV)

    The Qualified Person for Pharmacovigilance (QPPV) is an individual personally responsible for a Pharmaceutical company/Marketing Authorization Holders adherence to the legal requirements for drug safety activities. These activities include safety surveillance, reporting, quality system, documentation, training and benefit/risk assessments.

  • Pharmacovigilance System Master File

    The revised regulations for the European Union now has a requirement for a Marketing Authorization holder to maintain a document with all information relevant for safety of a marketed product. It is the responsibility of the QPPV that the Pharmacovigilance Master File is complete and always up to date. Technically it is normally not one physical document but an framework with components maintained in different repositories and systems. However it as to be available for inspection at anytime.

  • Audit

    A pharmaceutical company is required to perform internal audits of the Quality Management system related to drug safety. These audits are intended to confirm that a necessity components including  policies, procedures, guidelines, validations and training are conforming wil global requirements  and that they are appropriately documented. In most countries there are an expectation that all parts of the drug safety organization and process is audited internally at least every two years

  • Expedited Reporting

    Expedited reporting is at the core of Pharmacovigilance and Drug Safety. Timely processing, correct coding and medical review is critical for regulatory compliance as well as company understanding of product risks. The expedited reports is the basis for safety surveillance activities that include Signal Detection and Risk/Benefit Assessments.

  • Periodic Reporting

    Periodic Reporting to Regulatory Agencies, Ethics Committees are absolute requirements. Periodic Benefit Risk Evaluation Reports (PBRERs) reports for marketed products and Development Safety Update Reports (DSURs) for development products must be submitted in most jurisdictions. But some countries have their own requirements like the FDA required PADER report and the European QSURs and SSURs to Investigators and Ethics Committees.

  • Benefit/Risk Management

    Formal Risk/Benefit assessments have become an integral part of all periodic reporting in the form of PBRER post marketing reports and DSUR reports related to clinical development. In these reports it is required to assess the known Risk/Benefit profile for the drug and propose actions necessary to clarify any potential changes to the Risk/Benefit profile. Apart from the periodic reports; Risk/Benefit analysis should also be an integral part of day to day business in the drug safety function of any Pharmaceutical company

  • Pregnancy Surveillance

    Collecting information about pregnancies is not new and the requirements for collection of data was imposed after the Thalidomide disaster in mid 60′, but of often it is unclear how to interpret a few cases of malformations. Regulators have a tendency to stay cautious and take a drug of the market if there is any indication fetal safety issues. A proactive approach to pregnancy surveillance can save both patients, products and the company when done right and early.

  • Data Privacy Management

    Data Privacy is quickly becoming one of the most important and complicated issues for the pharmaceutical industry. The laws are often unclear, contradictory and vastly different around the globe. Conducting clinical development while maintaining compliance with Data Privacy regulations require a substantial and focused effort. Despite the unclear requirements – Failure to comply has severe implications for companies and responsible staff.

  • Signal Management

    Safety reports are constantly coded and added to the safety database. All this data is the bases for identification of new potential safety issues with your products. Effective tools to search the database and identify useful signals is essential to keep the product safe and for you to know before the regulatory agencies start asking the critical questions.

  • Procedural documentation

    The drug safety/pharmacovigilance function of a Pharmaceutical companies are required to keep a quality management system in place. A central part for the quality management system is written policies, procedures and detailed work instructions as well as documentation for review and training in these instructions by all relevant staff in the company, suppliers, contractors and partners. In the European Union the Pharmacovigilance System Master File is one of the tools to keep oversight.

  • eManual

    In Drug Safety and Pharmacovigilance law’s, guidances, requirements and procedures are constantly changing. Traditional paper based procedural documentation is no longer practical to maintain. Modern and well proven open-source technologies are now available to deploy in your organization at a very low cost which will allow fully electronic work instructions that are always up to date and meet the expectations of the Regulatory Agencies

  • Medical Review

    Medical Drug Safety assessments are needed for single case reporting as well as for agency enquires, filings and aggregate reports. These assessments require medical insight as well as a a broad knowledge of regulations and global expectations

  • Inspections

    In a heavily regulated area like Drug Safety national competent authorities will inspect your compliance with local and regional regulations. Your internal audits will prepare you to some extent for inspections, but getting ready for inspections require much more of your organization. Procedures for the inspections have to be in place, staff have to be trained, inspection room in order, briefing room, debriefing room, operations room and all with staffing. Before the inspection appropriate mock inspections have to take place and corrections have to be implemented. The better you are prepared to more time you save after the inspection where corrections of failures can be extremely costly and disruptive for the whole company.

  • Risk Management Plans

    It have become evident that a lot of safety information is missing when a new pharmaceutical product is introduced on the market. Even with the large scale clinical trials required for approval these days a lot of unexpected events can show up when the product is introduced on the market. So of these gaps in information is known at the time of approval and others show up later. Most authorities around the world now require an EU style Risk Management Plan where known and potential risks must be listed as well as measures that will be taken to mitigate these risks. This can include improvements to the label, controlled distribution, observational studies, interventional studies, pregnancy registries just to mention some. All this must be detailed in the Risk Management Plan.

  • Oberservational Studies

    Observational studies are a great tool for following the safety profile of a product after it has been introduced on the market. Your the regulatory agencies may have concerns what will happen when the product is introduced on the market. Cardio-Vascular problems, Infections, Pregnancy issues, Interactions etc. can all be concerns you will need to monitor.
    If you want to avoid that the agency put limits on your authorization because some problematic events have been reported you have to make sure that you have necessary observational studies to document if the problem is real or not. All too many products have been removed from the market just to be reintroduced years later. Patients without product and millions of $ lost in vain. Be proactive and set up necessary observational studies early the are much less costly than other measures that may be imposed and it helps the patients.

  • Post Market Commitments

    It has become common for regulatory agencies to impose condition on approvals. Conduct of Paediatric and Adolescent studies after the product is on the market is standard and written into law many places. But there is often additional post market commitments in the form of clinical studies, distribution restriction or observational studies. All this to make sure that patients are not exposed to rare, serious risks which will only show up when the general population is exposed to the drug

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A team of experts with experience in all aspects of  Global Drug Safety and Pharmacovigilance is available to support you with consulting or information services tailored to your particular need.

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