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New Standardized Criteria to Identify Adverse Events of High Severity

pharmaceuticsPM CLINICAL takes a look at the concept of adverse event and possible criteria established by EMA to identify serious adverse events.

In recent years, the European Regulatory Authorities have launched a number of new initiatives to improve the field of Pharmacovigilance, which paved the way for new European legislation adopted in 2012. These efforts have also included the creation of the Pharmacovigilance Risk Assessment Committee (PRAC), known for improving the EudraVigilance database, public pharmacovigilance with the introduction of new training courses and a new medical monitoring services. Other important PRAC objectives include a faster intervention on patients by the regulatory authorities and a greater network that allows various drug users to exchange information.

These improvements can be applied in a wide range of medical events, which can happen for different reasons, mostly categorized as “serious”; causing the EMA to make a list of criteria to help pharmaceutical companies identify the right level of severity of them.

An adverse event can be defined as an “any unfavorable episode of a medical nature that happens to a patient or a subject participating in a clinical trial in which a pharmaceutical product is administered and does not necessarily have a causal relationship with this treatment “.

According to EMA, following the new regulations, the list of so-called adverse events designated records with 62 entries; containing serious medical events, often causally associated with drugs in various therapeutic / pharmacological cases that may occur due to the use of various health products: including anaphylactic shock, blindness, liver failure, pancreatitis, pulmonary hypertension, and ventricular fibrillation.

Therefore, the EMA decided to list them all, along with the working group of experts EudraVigilance. These were as follows:

• Death,

• Deadly disease,

• Request hospitalization or prolongation of hospitalization,

• Persistent or significant disability / invalidity,

• Congenital anomaly / birth defect

PM Clinical recommends use of expert support for all Pharmacovigilance operations, in order to obtain the best results in terms of Quality & Compliance. PM Clinical provides consulting services for drug safety and risk management for the collection, monitoring, evaluation and analysis of information on drug safety and the detection of new adverse events. Our team is composed of personnel with 30 years of experience in the area of pharmacovigilance and headed by a Director who is a qualified EU QPPV.

New Challenges in Pharmacovigilance: E2B (R3) and the evolution of information exchange in safety

drug test reportPM CLINICAL takes a look at the challenges that have occurred in the field of pharmacovigilance following new ICH Guidelines.

Pharmacovigilance always provides new challenges. The recent change is the new E2B (R3).

Furthermore, the exchange of security information has moved from paper to electronic format as a result of European regulation. Electronic submission is still made according to E2B (R2) specifications but in May of 2005, the ICH released a revised guideline: the E2B (R3). The exchange through the specifications of the E2B (R3) was published in 2015 and became effective in July 1, 2016. This change affects both the Pharmacovigilance and regulatory departments and will require modifications to comply with these requirements.

The main differences between the E2B (R2) and E2B (R3) integrated ICSR IG EU are different and have brought a new structure, new requirements and additional fields in the following activities:

  • mandatory use of causality assessment through SUSARs. This method of assessment should provide evaluation and EU result of the Assessment. The same assessment is used in E2B (R2), with the free text fields, while in E2B (R3) these fields are controlled by origin, method and result of the assessment, according to ISO ICSR.
  • amendment Reports: if corrections must be made, or a document needs to be attached, this can now be done before the document is sent.
  • Attachments: the E2B (R3) allows attachments such as literature articles or other documentation (e.g., autopsy reports or copies of laboratory results) to be incorporated in the ICSR XML format, whereas previously it was not possible.
  • The information is moved depending on the level, which varies from case to case depending on the severity, medical requirements and confirmation of the occurrence of the country.
  • Characterization of the role of the drug as “Drug not administered” that can be used to subscribe to events to highlight cases of medical errors.
  • additional data fields and or codes for the identification of medicinal products.

All these changes will lead companies to change their basis of “data security”. Organizations will have to plan the changes of the processes in advance, so as to follow E2B (R2) and E2B (R3) guidelines. In addition the above changes will affect the SOP and procedural documents as well as PSMF. The training of all personnel involved in the process is therefore of the upmost importance.

PM Clinical provides a complete package of security services for drug and risk management in the following sectors: collection, monitoring, evaluation and analysis of information on drug safety and the detection of new adverse events. Through a network of resources, we can provide data entry and case collection in a cost efficient manner, along with an expert advice in quality control and report preparation.

PM Clinical Names New Director of Pharmacovigilance

IMG_08092014_12032404 September 2015 (Rome, Italy) - PM Clinical today announced the appointment of Stefania De Santis to the role of Director of Pharmacovigilance to join its growing business line of pharmacovigilance applications, services and consultancy.

Stefania is responsible for strategic planning and workflow development within the pharmacovigilance department as well as quality assured delivery of pharmacovigilance services.

She is also qualified as EU QPPV.

Stefania brings almost 30 years of experience in the pharmaceutical industry to her new role with PM Clinical. She has been involved in various departments throughout her career, but since 1992 she has been dedicated to the field of pharmacovigilance in the role of Head of Corporate Drug Safety and qualified Deputy EU QPPV for a major pharmaceutical company. Stefania has extensive experience in all aspects of pharmacovigilance operations, in both pre-registration and post-marketing settings, and her areas of expertise include case processing, PSUR and DSUR preparation, ICSR/SUSAR electronic transmission to the EMA, safety database validation, safety variations, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities. She is certified by the EMA for the use of Eudravigilance and EXVMPD (Medicinal Product Dictionary).

Daniela Marcozzi, VP of Pharmacovigilance Services, said, “I am pleased to announce the appointment of Stefania to our pharmacovigilance team. Not only is she an expert on the various aspects of pharmacovigilance operations and safety systems, she is also a qualified EU QPPV and can step into this role when needed. Stefania is no doubt going to be a valuable asset to our pharmacovigilance team and to any client needing support with safety systems, case processing, quality assurance and compliance within the pharmacovigilance team”.

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About PM Clinical

PM Clinical is an international Clinical Research Organization (CRO) providing expert and innovative clinical, regulatory, pharmacovigilance and quality assurance solutions to drive the development of products and devices to market in a timely and cost-effective manner. We provide product development and regulatory consultancy, clinical project management and monitoring services for pre-clinical through the whole product development program and post-market product life cycle as well as offer a full package of clinical consultancy, biometrics and pharmacovigilance services and safety systems. PM Clinical completes its portfolio by helping companies operating in the drug and device development sector with quality and compliance solutions to meet regulatory requirements.

PM Clinical Opens Office in Rome

Rome, Italy (02 April 2015) - PM Clinical is pleased to announce that it has opened a second office based in Rome, Italy.


PM Clinical is an international Contract Research Organization which provides expert and innovative clinical, regulatory and quality solutions to drive the development of products and devices to market in a timely and cost-effective manner. PM Clinical already has an office in Maidenhead, United Kingdom.

The Rome office was established as the company’s Pharmacovigilance and Quality center where all services related to pharmacovigilance will be carried out. PM Clinical’s Vice President for PharmacoVigilance Services and QA & Compliance Consultancy, Daniela Marcozzi, is based in the company’s Rome office.

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