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What is an ICSR? An ICSR is the individual case safety report that captures information needed to support the reporting of the drug following the adverse event. We report on valid cases that have the minimum reporting criteria in compliance with the specified timelines.
Your company needs to be compliant with the regulation changes for ICSR reporting. Without accurate and compliant ICSRs, you could face costly penalties for not complying with the EU drug safety laws.
When your company sets up contractual arrangements with Almond Pharma, a detailed Safety Data Exchange Agreement (SDEA) will outline the processes for the exchange of safety information, including timelines and regulatory reporting responsibilities avoiding duplicate reporting to the necessary authorities.
Our drug safety consultant team make sure your submissions to the appropriate authorities are seamless and compliant in order to help you avoid heavy and costly penalties accumulated through non-compliance.
Almond Pharma uses a validated and secure safety database with reliable backup and disaster recovery programmes in place. We offer a cost-effective solution for managing your safety data as well as taking care of your company’s future needs for processing ICSRs.
Our experienced pharmacovigilance physicians are experts in reviewing MedDRA coding and medical assessments of all cases with the thorough quality control service we offer for each report. For electronic reporting we have a specialised submissions team who are trained users of EudraVigilance. We understand the need for time restraint compliance. If need be, we can tailor our established standard practices to your specific requirements.
Electronic Reporting of Suspected Unexpected Serious Adverse Events (SUSARS) is now mandatory in many global territories.
Almond Pharma handles the onerous task of registration and setting up electronic reporting routes for the Pharmacovigilance system. Experienced and trained personnel ensure that expedited reporting meets the regulatory requirements in each trial territory. Whether electronic or hard copy, we offer consolidated expedited reporting services.
Medical Writing Reports
If companies have a marketing authorisation in the EU for their drugs, they are required to prepare detailed approval documents, on all their products. We prepare postmarking documents such as PSURs and clinical documents such as DSURs.
These documents provides an overview of safety and efficacy (GVP Module VII) over a defined interval: they require careful preparation according to a standard format in order to comply with the regulations and must meet tight deadlines for submission. They are considered important pharmacovigilance documents by the authorities and they are subject to intense scrutiny at the time of inspection in the EU.
Drugs safety monitoring activities include the collection and organising of drug safety data. It is imperative that any new safety findings observed in patterns be accurately and timely identified. The appropriate evaluation and timely identification of possible signals is an important Pharmacovigilance activity which will in turn protect your patients as well as your company against any lawsuit and action taken by regulators.
Signals become complex when they specify potential new risks in relation to a particular medicinal product, or when the potential for the expected risks change. The data which informs the signal detection process comes from various sources such as Pharmacovigilance Literature Screening, other types of non-clinical, non-interventional studies and other forms of active assessment including risk-benefit monitoring. Almond Pharma Pharmacovigilance services consultants make sure your Safety Signals Management activities are systematically comprehensive and compliantly processed.
According to Module VI of the EU Guideline of Good Pharmacovigilance Practices (GVP) , the regulators expect every marketing authorisation holder to incorporate literature screening procedures as an integral part of your daily drug safety operations.
Almond Pharma operate a comprehensive Worldwide Pharmacovigilance Literature Screening Service as part of our drug safety services. At least once a week, we will systemically monitor the “active substances”, assessing the relevant database by screening abstracts for the identification of:
- Potential new and significant safety findings
- symptomatic overdose, abuse or misuse
- Identification of potential ICSRs
- Pregnancy outcomes (including termination) with no adverse outcomes;
- Use in paediatric populations plus more.
Why Choose Almond Pharma
Almond Training, is a sector where we bridge the gap between lack of experience and qualification, by offering industry training courses. We bridge the gap between being qualified and inexperienced. Our intense courses are very interactive, led by industry experts.
Our consultants include industry experts who have long been at the forefront of this activity. We are adept at identifying and evaluating signals, and we take pride in our common-sense approach to the matter simplifying the process and ultimately reducing your costs. Our experts carry out benefit-risk analysis and can help you communicate effectively the message about new safety concerns. Our experts can communicate this message to both individuals within your company and regulatory authorities.
The benefit of contracting Almond Pharma to do your Literature Screening for you is that our team have years of experience in this particular area and can comprehensively manage your literature screening requirements in the most cost-effective way possible.
For purposes of signal evaluation, we can also carry out identifying safety concerns for inclusion in PSURs or literature searches.