Post Marketing Safety and Clinical Safety

PharSafer® has extensive experience for safety reporting multi-nationally in both post-marketing spontaneous reporting and for clinical trial reporting around the world.

Safety reporting for globally registered products or for multi-national clinical trials can require both a complex and diverse set of rules and timelines to be observed.

All PharSafer® personnel have extensive knowledge and training of the various country requirements for safety reporting to enable our clients to report individual cases correctly, and in an appropriate timeframe to remain compliant with the legislation.

All clients are provided with up to date safety reporting plans (as devised by PharSafer®) for their products which identifies by country the various requirements for safety reporting both for post-marketing and clinical trial situations.

These reporting plans are version controlled and dated documents that are monitored to ensure that any changes to legislation by any country can be adapted into the reporting plan to ensure compliance.

PharSafer® has experience of having conducted such safety reporting both for clinical trials and post-marketing globally for many Companies both for drugs; devices and vaccines.

Our experience in Clinical trials has ranged from Phase I – IV studies multi-nationally throughout the EU; USA; Canada; S America and S E Asia.

For Clinical trials we have worked with blinded studies; worked with Independent Data Monitoring Committees set up by clients and Risk Management Studies.

PharSafer® has also worked with Marketing in the conduct of Marketing studies and Research Outcome activities to ensure that all safety related information has been properly reported.

Individual Safety Case (ICSR) Processing

This involves data entry; data QC check; medical review; reportability assessment; electronic/paper reporting; follow up; case closure; case file archiving.

This can be performed for post-marketing and clinical trial cases (SAEs and SUSARs) and captured within the PharSafer® validated and password protected adverse event safety database. Reports can be generated electronically (or paper format) to the Regulatory Agencies from this database and compliance metrics produced for Companies for notification of adherence to the regulations.

Similarly the database can generate, periodic summary tabulations; line-listings and perform analyses for identifying potential signals and tabulations and specialized queries used in safety reviews.

 

PharSafer® has detailed procedures for the production, management, assessment and reporting of individual case safety reports (ICSRs) and suspected, unexpected, serious adverse reactions (SUSARs) globally.

PharSafer® staff are also responsible for obtaining follow up information to adverse reaction (ADR) reports to obtain comprehensive information that will allow a proper determination of both causality and the possible mechanism by which the reaction occurred thereby looking to prevent or minimize its appearance.

Literature Searching

PharSafer® are able to perform literature searching on behalf of clients. Currently, in the EU and in accordance with the regulations such searches are conducted weekly and we set up weekly search streams that are generated automatically for clients and are approved by the clients for their content to ensure capture of all types of articles involving the safety of the Company products.  Literature searching is performed using MeSH terms to enhance possible ADR identification.  PharSafer® are performing such searches for Companies in the USA; Canada; throughout the EU; and SE Asia.

We have a system in place for the ordering of articles to perform expedited reporting; signal detection; benefit risk assessments and analyse Class related events (which may be used in PSURs).

Additionally, PharSafer® also perform competitor analyses to assess both products treating same indications; same Class of products; disease treatments and for products in development too, to assess current gold standard treatments versus the Company product.

All staff have been extensively trained in literature searching and all literature search streams are internally reviewed and approved by a physician; pharmacist and safety scientist as well as the client.

Compassionate Use/Named Patient Studies

PharSafer® has worked in many situations involving compassionate use programmes, either as extensions to clinical trial studies or for use during the products post-marketing phase in countries where licences have yet to be obtained.

There is a need for such programmes to follow the varied legislation in terms of safety monitoring and PharSafer® has multi-national experience of conducting very large compassionate use programmes including using such data as supportive data in further licence submissions.

Electronic Reporting of ADRs


Eudravigilance Registration

Since November 20th 2005 there has been a requirement in Europe to report ADRs electronically and although there is no single simple system in the EU for safety reporting, PharSafer® can ensure that you are properly registered and reporting electronically (where possible) to the various Regulatory Authorities in the EU to ensure maximum compliance to the EU legislation.

A number of the Member States in the EU require different types of electronic reports to be submitted to them. Additionally, as well as requiring different electronic formats the various countries also require the licence holder to test with them individually beforehand.

To begin the process the Company must apply to perform the electronic reporting with the EMEA and test with the EMEA first. Once this has been approved, then the Company can proceed to country specific reporting according to National legislation. To register with the EMEA, the details of the EU QP PV must also be declared.

PharSafer® are performing this activity for many clients across the EU, Japan, SE Asia and the USA and has done Eudravigilance registration for many Companies from the EU; USA and Japan.

Additionally, proof of registration to Eudravigilance is a requirement of the DDPS and without proof of this, the Company will not be granted a licence. Similarly, lack of notification of the EU QP PV will prevent the licence being assessed.

Medical Device Safety

The legislation regarding Medical Device Safety is no less stringent than the Pharmaceutical medicines requirements.

PharSafer® has been involved and continues to be involved in multi-national medical device reporting of adverse incidents.

The Medical Device definition regards any product that does not perform its main activity via a pharmacological activity to be a Medical Device. The reporting requirements for Medical Devices are very different to the medicines legislation and the Class categorization of the medical device depends either upon the level of invasiveness of the device for the patient or the perceived risk to the patient concerning the placement of the device.

The PharSafer® validated safety database also captures and reports medical device reports for global safety reporting. All staff have been trained on medical device reporting and there are standard operating procedures in place in the Company to not only report medical device reports but also for the assessment of possible unexpected incidents and assessments of conformance and possible changes required.

PharSafer® are well aware of the differences in device vigilance which operate around the world. From Europe with the centralised registration via an approved CE Mark and Notified Bodies as annual Inspectors through to the differing schemes in the USA, Canada etc… and the different categories of Class of Device and reporting rules; the experienced PharSafer® staff compile safety reporting plans to allow reporting of medical device incidents using the various Regulatory Authority incident forms globally.

Device/Drug Combinations and Drug/Device switches

Increasingly there has been a new group of products that are being licensed that are either drug-device combinations requiring specialist knowledge in both disciplines or devices that are drugs in some regions and devices in others.

Experienced PharSafer personnel can ensure that you have the correct assessments of your products to ensure Regulatory compliance.

Vaccine & Biological Safety

PharSafer® also work with vaccine Companies and the PharSafer® safety database will capture and report all types of vaccine reports globally.

Advanced Therapies

PharSafer® works with a number of Companies that have the so-called advanced Therapy products derived from stem cell research and the use of such therapies for cell regeneration and replacement. This is a vital and new area of research in the Pharma Industry and pushes the knowledge and methods of safety assessments because the products do not fit the normal pharmacological response model exhibited by many standard medicines.

PharSafer® again have procedures in place in line with the most up to date legislation in this area for the accurate interpretation of potential adverse events and any long term safety assessments in this particular sphere of treatment.