How does Cevidra carry out post-marketing monitoring for your medicinal product?

#PostMarketingMonitoring #MAHolder

Together with the MA holder and the manufacturer, Cevidra carries out product quality monitoring, manages any adverse event and processes medical information requests.

Medical Information
Pharmacovigilance
Cevidra’s Quality system

Medical Information

Medical information are the answers sent by the Exploitant to health professionals’ questions on the various pharmaceutical or medical properties of the marketed products.

Medical information is provided in response to requests from health professionals, and is thus distinct from promotion, which is a proactive approach by the laboratory aimed at health professionals.

Who can respond to requests for medical information?

Health professionals’ questions are answered by qualified staff trained in the products marketed.

Pursuant to the technical terms agreed to with the MA holder, CEVIDRA provides qualified resources (i.e. pharmacists) to process medical information requests.

Pharmacists are qualified based on a product-specific training built around the scientific documentation and support provided by the MA holder. Once qualified, medical information requests are processed by CEVIDRA.

How are requests for medical information processed?

Cevidra is organized to provide this service 24 hours a day, 7 days a week.

Frequent Asked Questions or FAQ

The marketing authorization holder may provide the Exploitant with a document in which answers to the most frequently asked questions are already formalized and validated by its medical department.

Subject to review and approval from CEVIDRA’s Chief Pharmacist, this document then serves as a reference to answer health professionals queries.

How to qualify a Medical Science Liaison (MSL)?

At the request of the MA holder and with their support, Cevidra can train and qualify MSLs.

The MSL qualification is based on a training program prepared and validated in advance by the MA holder and Cevidra.

This plan provides for scientific and regulatory training on the product and the pathology, as well as training on the rules applicable to those directly dispensing medical information to patients.

This training also includes a reminder of the applicable regulation concerning the promotion of medicinal products, the DMOS law and transparency requirements.

MSL

Pharmacovigilance at the Exploitant level

The purpose of pharmacovigilance is to monitor, assess, prevent and manage the risk of adverse reactions resulting from the use of medicines. Cevidra, as a Pharmaceutical Exploitant, has a local Pharmacovigilance system that complies with the requirements of the French authorities.

Cevidra provides the MA holder with its organisation and resources to ensure that all pharmacovigilance requirements are met efficiently.

How to interface the MA holder’s pharmacovigilance with that of the Exploitant?

Cevidra has a local pharmacovigilance manager (RPV) who is declared to the ANSM. This person is defined by the Pharmacovigilance Best Practices as the contact for pharmacovigilance on French territory. In France, it is required of the Exploitant that they have a RPV residing in France and linked to a qualified person at European level (EUQPPV).

Within the framework of a partnership with the MA holder, this person acts locally under the responsibility of the European Qualified Person in Pharmacovigilance (EUQPPV). The sharing of responsibilities and pharmacovigilance activities between CEVIDRA and the MA Holder is discussed and formalised upstream through a written agreement, called SDEA (Safety Data Exchange Agreement) or PVA (PV Agreement).

This organisation thus ensures that the MA holder and Cevidra comply with the regulations and local and European Good Practices in pharmacovigilance operations.

How does Cevidra ensure compliance of pharmacovigilance operations?

CEVIDRA relies on its local PSMF (Pharmacovigilance System Master File) and Quality Management System to ensure compliance with local and European requirements.

Our staff are trained annually in Pharmacovigilance. The RPV and their delegate ensure local PV operations 24 hours a day, 7 days a week.

Exploitant

At the Exploitant level, the system is centered on the collection and processing of spontaneous reports and the registering of local adverse reactions in a local database with the implementation of a signal detection system. We also monitor product misuse and liaise with public authorities. Depending on the agreements in place with the MA holder, we can handle the local literature review.

Pharmacovigilance

Pharmacovigilance activities that are the responsibility of the MA holder are not covered by the Exploitant’s Pharmacovigilance system. Nevertheless, Cevidra can offer, via its qualified provider, a Pharmacovigilance service comprising the requirements that apply to the MA holder (e.g. PSMF, global database, declaration on Eudravigilance, …) in addition to those of the Exploitant.

Cevidra quality and undertaking

Cevidra’s management is responsible for the company’s processes regarding compliance with regulatory requirements, employee and patient safety and the quality of products, services and scientific data.

To achieve this, CEVIDRA has put in place a quality management system which complies with GMP and GDP, ensures the implementation of our quality policy and guarantees the performance of the services we offer.

How are customer complaints handled?

In our relationship with the marketing authorisation holder and the product manufacturer, we systematically set up a technical specification agreement or QTA (Quality and Technical Agreement).

This agreement clarifies the division of responsibilities for batch distribution and manufacturing operations.

Our logistics and quality teams handle customer complaints to respond immediately to patient needs and to carry out the necessary diligence.

Complaints-process

The complaint is immediately registered and sent to the Pharmacist who analyses the seriousness of each complaint. When the complaint relates to a product Quality defect, the defective product is recovered and sent by Cevidra to the manufacturer for analysis and the implementation of the corrective and preventive actions appropriate to the situation.

What are our obligations in the event of a quality defect?

We take responsibility for compliance with local requirements for reporting quality defects to the ANSM.

Quality defects deemed by the manufacturer and Cevidra to have a potential impact on patient safety must be reported to the ANSM following a process and filing documentation imposed by the authorities.

Depending on the seriousness of the defect and the impact on the patient, public authorities, the manufacturer and/or Cevidra may decide to recall the incriminated batch or batches. The process for the decision to recall a batch by the manufacturer, the MA holder and Cevidra is formalized in the QTA drawn up beforehand.

Cevidra’s structure is organized to initiate, implement and monitor the recall of a batch alongside public authorities. The operating laboratory is required to send a message subject to prior validation from public authorities to all recipients of the incriminated batch and to monitor the quantities returned through the “DP Recall Batch” portal made available to Exploitants in France.

Recall-batches

A permanent focus on the detection of falsified products

Cevidra’s quality processes enable us to detect the possible introduction of falsified products into the medicinal product distribution circuit. We are particularly vigilant on this subject when qualifying our suppliers and when checking products upon receipt. We also check for the absence of falsified products during customer complaints and during the control of drug returns.

Any suspicion of falsified medicines is dealt with and checked with the manufacturer before being reported to the authorities.

Do you know the French regulations on security stocks?

Public authorities have introduced in 2021 obligations on stocks held by Pharmaceutical Exploitants, with stock levels varying according to the product’s therapeutic value.

Indeed, the law requires the Exploitant to classify the products it distributes as Medicinal Products of Major Therapeutic Interest (MITM) or not. This classification of products is established according to several criteria based on seriousness of the pathology and the availability of alternative treatments in France to this medicinal product’s place on the French market.

When this analysis leads the product to be classified as MITM, then the law requires the Exploitant to:

  • Draw up a shortage management plan. This shortage management plan, carried out in collaboration with the MA holder and in accordance with the recommendations of the public authorities, analyses the risk of the medicinal product running out of stock at different levels of its manufacturing, distribution and marketing process.

    This shortage management plan should enable the MA holder and the Exploitant to implement actions aimed at reducing the risk of shortages. This shortage management plan is updated and registered with the ANSM each year by the Exploitant.

  • Constitute a minimum of two months’ safety stock

 

Also in connection with this 2021 regulation, the Exploitant is required to register on the ANSM platform (TRUSTMED) any disruption or risk of disruption of supply of the products it markets and that are classified as MITM.

CEVIDRA drafts with the manufacturer and the MAH the appropriate documentation to meet these local requirements in terms of safety stock, shortage management plan and declaration of shortage or risk of shortage.

Main takeaways