Operational Pharmacovigilance services

 

Operational pharmacovigilance solutions comprise all tasks which keep your pharmacovigilance system running, including literature review, management of ICSRs including adverse event reporting and narrative writing, the pharmacovigilance risk management plan (RMP), reference safety documents as CCSI, CCDS, SPC and PIL, PSUR writing in PBRER format, DSURs, signal management, support with the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and much more.

 

Qualified person for pharmacovigilance (QPPV), preparation and maintenance of SOPs and quality management system as well as the (electronic) pharmacovigilance system master file (PSMF) are under Pharmacovigilance System.

 

 

 

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In order to avoid duplication of efforts by the MAH, EMA has launched the Medical Literature Monitoring service (MLM service): the Agency collects information on suspected adverse reactions published in medical literature and lists them in EudraVigilance and/or on the MLM page.

 

This results in one more obligation to be fulfilled by the MAH: screening the MLM results periodically to identify any possible relevant cases for the MAH's own product(s).

 

Lindeq can monitor the MLM results on a regular basis for you, irrespective of Lindeq is responsible for your case management or not.

 

For more detailed information please contact us directly. Together we will find the best solutions to correctly target your needs.

 



EudraVigilance (EV) is the European central database for electronic reporting and evaluation of adverse reactions captured during clinical trials or post marketing. European Sponsors and Marketing Authorisation Holders are required to be registered with EV to fulfil the obligation to report SUSARs and ICSRs.

Lindeq can help you complete the registration documents and register with EV.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs. 



Pharmaceutical companies are obliged to screen the worldwide literature for case reports and any other important safety data on products for which they hold a marketing authorisation.

Lindeq has solid experience with searching literature databases and screening database hits for new safety data on medicinal products.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Whether it is an initial report or a follow up report, Lindeq will manage your ICSRs and SUSARs throughout the whole process: From receipt, data entry, narrative writing, possible follow up and medical assessment, to electronic reporting.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.

 

Do you not have a validated safety database yet? In collaboration with the Danish pharma IT developer BaseCon Lindeq offers a safety database solution including set up, validation and maintenance.



Our team prepares well-written case narratives for your ICSRs, SUSARs, PSURs, research reports, regulatory files etc.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



SUSARs and ICSRs have to be reported electronically (E2B) to EudraVigilance (EV) and/or to all concerned Competent Authorities. Therefore, your company has to be registered with EudraVigilance. Once registered, Lindeq reports your initial and follow up reports that fulfil the criteria for expedited reporting either via our fully validated E2B compliant safety database, or alternatively through the EV Web Trader, the EMA reporting tool for ICSRs and SUSARs.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



The Risk Management Plan (RMP) is a stand-alone document describing your product's risk-benefit profile. It is advisable to write your RMP early in the drug development phase as a RMP may also provide a good basis for your clinical protocol and Investigator's Brochure.

Our experienced Risk Management Experts help you identify potential risks. They also advise you with regard to future risk minimisation activities other than routine pharmacovigilance for your product's entire life cycle.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs. 



Preparing a Periodic Safety Update Report (PSUR) often means significant amount of work for the pharmacovigilance department. Our experts have long-term experience with writing PSURs regardless of the products being innovative or generic, therapeutics, diagnostics, or vaccines. The PSURs are prepared in the required PBRER format and we can use either your company's template or the Lindeq template.

 

For more detailed information please contact us directly. Together we find the best solutions to your individual situation.



The Development Safety Update Report is the common standard for periodic reporting on drugs under development. The DSUR replaces the EU Annual Safety Report (ASR) and is accepted by the FDA as a replacement for the IND Annual Report.

The format of the DSUR is designed to show early potential safety issues. It includes the current interpretation and management of risks to exposed patients, describes changes in the product's safety profile and updates of the clinical development program.

Our team is up-to-date on this report and can advise you regarding the compilation of the report as well as prepare your complete DSUR.

 

For more detailed information please contact us directly. Together we find the best solutions to your individual situation.



A CCSI is a part of the Company Core Data Sheet (CCDS) and comprises a product's safety information. Lindeq can assist you in the process of writing the CCSI, based on study information, post-marketing data and literature review.

Our pharmacovigilance experts will assist you with updating the CCSIs as new information arises.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Reference safety documents (US: labelling documents) like CCDS, CCSI, SPC, PILs have to be regularly revised and updated as needed. At Lindeq we have long-term experience with updating the reference safety documents, both internal documents like the CCDS and the CCSI as well as regularly documents like the SPC and PIL.

Furthermore, we can translate Reference safety documentation to all Scandinavian languages plus Dutch, Finnish, French, German, Greek, Hindi, Italian, Lithuanian, Portuguese, Russian, Spanish, and Tamil.

 

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Regulatory Authorities require MAHs to have a procedure to detect and to identify possible signals of new adverse reactions and changes in frequencies of known reactions. Lindeq can perform signal detection and signal analysis of your safety data. If new data is having an effect on the risk-benefit balance, we can provide the appropriate expert advice as well as assist in communication with regulatory agencies.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Lindeq's experienced pharmacovigilance experts provide medical review and case management for all kind of reports, including PSURs, DSURs, RMPs. Reviewing the documents, checking for completeness and evaluating the report's quality are parts of the medical review. Secondly, diagnosis procedures and diagnosis are also in the focus of our medical reviews.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Lindeq has persons certified in XEVMPD after successful completion of the XEVMPD training courses offered by EMA.

The EMA issued a Legal Notice on 5 March 2012 requiring all MAHs to submit information on their medicinal products to the EudraVigilance Medicinal Product Dictionary (EVMPD) using the new XEVPRM format. For existing products, the MAH is required to submit such information within 2 July 2012. In order to submit information to EVMPD, the MAH is required to have a person trained in XEVMPD and as a third party provider we can represent the person trained from your organisation.

"Users that have successfully completed the XEVMPD training courses offered by the Agency will be able to start the electronic submission of information on medicinal products using the new XEVPRM format after completing the necessary registration process." (EMA, 5 March 2012)



Although the Summary Bridging Report (SBR) and the Addendum Report (AR) are nearly extinct within the EU, several non-EU authorities still request them.

Our experts can prepare your SBR as well as the AR regardless which kind of product is in focus.

 

For more detailed information please contact us directly. Together we will find the best solutions to your individual situation. 

 






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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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Cosmetovigilance
Full range of cosmetic product safety services for all different types of cosmetic products
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Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)