The EU changes on the regulatory side have been significant. It has not only seen pharma companies face a new challenge to meet the requirements but also regulated medicinal products manufacturers, distributors and Pharmacovigilance professionals. The Local Person for Pharmacovigilance (LPPV) is one of the essential players in this field to ensure safety and compliance.
What is the Local Person for Pharmacovigilance (LPPV) in the EU?
The Local Person for Pharmacovigilance in the EU ensures that a company complies with pharmacovigilance requirements when marketing a medicinal product in that Member State. This includes ensuring that a company has systems and processes to collect, record, report and follow up on suspected adverse reactions.
The Local Person for Pharmacovigilance is also responsible for liaising with the competent authorities on pharmacovigilance matters and representing the company in dealings with these authorities. In addition, the Local Person for Pharmacovigilance may be required to provide input into risk management plans and participate in safety reviews.
It is important to note that the LPPV role is distinct from that of the Qualified Person for Pharmacovigilance (QPPV). The QPPV is responsible for overall pharmacovigilance activities within a company, including oversight of national LPPVs.
Why Do You Need an LPPV?
The Local Person for Pharmacovigilance in the European Union (EU) is a crucial figure in ensuring the safety of medicines. They monitor and report adverse events, collect and maintain patient data, and conduct risk management activities.
The Local Person for Pharmacovigilance plays a vital role in ensuring that medicines are safe and effective. They are the first line of defence against potential safety issues and can help prevent serious problems. Reporting adverse events and carrying out risk management activities help keep patients safe and ensure that medicines remain effective.
You might need a local person for pharmacovigilance in the EU for many reasons. First and foremost, they can help ensure that your clinical trials are conducted in compliance with all applicable laws and regulations. They can also help you navigate the often-complex process of obtaining marketing authorization for your product.
In addition, a local person can be a valuable resource in understanding the preferences and needs of individual European regulators. They can also provide valuable insights into the competitive landscape in the EU, and help you develop strategies for success in this highly regulated market.
The local person for pharmacovigilance also works closely with the European Medicines Agency to monitor the safety of medicines and keep up to date with the latest research.
Ultimately, working with a local person for pharmacovigilance in the EU can help you bring your product to market more quickly and efficiently while minimizing risk and maximizing the opportunity for success.
How do you become a Local Person for Pharmacovigilance in the EU?
The Local Person for Pharmacovigilance in the EU ensures that a company’s pharmacovigilance activities comply with EU regulations. They also liaise with the European Medicines Agency (EMA) and National Competent authorities on pharmacovigilance matters.
To become a Local Person for Pharmacovigilance in the EU, you must have a scientific or medical degree and experience in pharmacovigilance or clinical research. You must also be fluent in English and have a working knowledge of another EU official language.
Which regulations exist for the LPPV role?
Numerous regulations exist for the LPPV role. The most important of these is the Good Pharmacovigilance Practices (GVP) Regulation, which came into force in 2012. This regulation requires companies to have a qualified person responsible for pharmacovigilance (QPPV) who resides in an EU Member State. In addition, the QPPV must be available to the competent authorities and stakeholders on a 24/7 basis.
The LPPV role is also subject to the Clinical Trials Directive, which requires companies to appoint a Local Trial Coordinator (LTC) for each clinical trial conducted in the EU. The LTC ensures that the trial is conducted following the protocol and applicable regulations.
In addition, the LPPV must comply with all national regulations relating to pharmacovigilance, including those relating to adverse event reporting.
Regional differences for the LPPV in the EU
There are several reasons why the Local Person for Pharmacovigilance (LPPV) in the EU may differ from country to country. The first reason is that each Member State of the EU has its rules and regulations regarding pharmacovigilance. In some cases, these rules may be more stringent than those of the EU, while in others, they may be less. As a result, the LPPV in each Member State may have different responsibilities and duties.
Another reason for regional differences in the LPPV is that there may be different levels of experience and expertise among LPPVs in different countries. In some cases, an LPPV may have many years of experience working in pharmacovigilance, while in other cases, an LPPV may be new to the field. This can lead to differences in how each LPPV approaches their work.
Finally, cultural differences can also play a role in creating regional differences among LPPVs. For example, some cultures emphasize individual autonomy more than others. This can lead to LPPVs in these cultures taking on a more proactive role in ensuring patient safety, while LPPVs from cultures that emphasize collectivism may take a more passive approach.
Outsourcing the LPPV role to a CRO?
The LPPV role in pharmacovigilance is to ensure that companies comply with the requirements of the European Union (EU) Pharmacovigilance Directive. The directive requires companies to have a designated LPPV responsible for the safety of medicines in their country.
Outsourcing the LPPV role to a CRO can be an effective way to ensure compliance with the directive. CROs can provide expert knowledge and support in all aspects of pharmacovigilance, from data collection and analysis to reporting and risk management.
In addition, outsourcing the LPPV role can free up internal resources so that companies can focus on other areas of their business. It can also be used as a cost-saving measure, as CROs usually charge lower fees than in-house pharmacovigilance departments.
Building Health Literacy: The Value of Good Writing
Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.
Proper Publicizing in CEECs – Path to Successful Social Media Commercials
With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.
What do you need to know while preparing RMP for EAEU and CIS region?
Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.
MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics
Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.
Biomapas appoints Head of Global Pharmacovigilance
March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.
What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.
Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions
PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.
Harmonization of EAEU GVP: CIS is getting more vigilant than ever before
On the 6-7 March, Biomapas Pharmacovigilance Department management and team from the CIS region participated in a meeting in Minsk. It was dedicated to strengthening collaboration between the team members as well as updating knowledge on latest PV trends. We discussed the most recent releases of legislation, such as Eurasian Economic Union Good Pharmacovigilance Practice harmonization and the importance of a teamwork approach with Biomapas’ PV Project Manager CIS, Aliaksandr Bakshtanovich, MD.
