Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It’s so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly.
What Is Regulatory Intelligence?
Regulatory Intelligence is the gathering and analysis of information on regulatory processes, requirements, and policies. It helps companies to understand the changing landscape of regulations and make informed decisions about their products.
Regulatory Intelligence is a critical tool for pharmacovigilance, as it can help identify new safety concerns and keep track of emerging trends. It can also help assess the impact of regulatory changes on a company’s product portfolio.
There are many Regulatory Intelligence sources, including government agencies, trade associations, news media, and commercial providers. However, to be effective, RI must be tailored to the specific needs of the users. For example, a company developing a new drug will need different information than a company marketing an existing drug.
Most Regulatory Intelligence programs include four essential components: monitoring, analysis, reporting, and communications.
- Monitoring is the process of collecting information from multiple sources.
- Analysis is the process of reviewing and interpreting the information collected.
- Reporting is the process of sharing the findings with stakeholders.
- Finally, communication ensures that stakeholders understand the implications of the findings and take appropriate action.
The Role Of Regulatory Intelligence in Pharmacovigilance
The role of regulatory Intelligence in pharmacovigilance is to identify, collect, and interpret information on medicines that may pose a risk to public health. This information helps regulators make informed decisions on the safety of medicines and how to best protect patients.
Regulatory Intelligence plays an important role in ensuring the safety of medicines by helping regulators:
- Understand the risks associated with medicines;
- Monitor the safety of medicines;
- Make informed decisions on the regulation of medicines;
- Protect patients from potentially harmful medicines.
Regulatory Intelligence is an essential part of pharmacovigilance and helps ensure that medicines are safe for patients.
Why is Regulatory Intelligence Important To Pharmacovigilance
Pharmacovigilance is the scientific discipline concerned with detecting, assessing, understanding, and preventing adverse effects of medicines. It is also crucial to pharmacovigilance because it allows for the optimization of drug therapy and the development of safer medicines.
The goal of RI is to support pharmacovigilance activities by providing early warning of changes in regulatory requirements that could impact the safety of a company’s products. RI also helps companies to identify gaps in their knowledge of global drug safety regulations and to develop strategies for addressing these gaps.
Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality worldwide. They are responsible for approximately 5% of all hospital admissions and 4% of all deaths annually. In addition, ADRs are a leading cause of outpatient visits, accounting for 2.2% of all office visits in the United States.
The importance of pharmacovigilance is underscored by the fact that ADRs are largely preventable. Pharmacovigilance programs can identify previously unrecognized ADRs and potentially hazardous drug-drug interactions. In addition, pharmacovigilance can help optimize drug therapy by identifying drugs that may be ineffective or need to be used with caution in specific patient populations.
An effective Regulatory Intelligence for Pharmacovigilance program can help biopharmaceutical companies to:
- Understand global drug safety regulations;
Identify changes in regulatory requirements that could impact their products;
Develop strategies for addressing gaps in their knowledge of global drug safety regulations;
Make informed decisions about product development, clinical trials, and marketing.
Integrating Pharmacovigilance With Other Functions
The field of pharmacovigilance has evolved significantly over the past few years, and regulatory Intelligence has emerged as an essential tool to help organizations keep up with the latest changes. RI can be defined as “the collection, analysis, and interpretation of data related to the regulation of medicines.”
Pharmacovigilance has traditionally been a siloed function within organizations, but the need for cross-functional collaboration has become increasingly evident. To be successful, pharmacovigilance must integrate with other functions such as clinical research, medical affairs, quality assurance, and regulatory affairs.
There are several benefits to integrating pharmacovigilance with other functions:
- Increased Efficiency: Integration allows for more efficient use of resources and eliminates duplication of effort.
- Improved Communication: Open communication channels between different departments allow for a better exchange of ideas and information.
- Shared Responsibility: When different departments share responsibility for pharmacovigilance activities, it leads to increased ownership and commitment from all involved parties.
- Enhanced Quality: The collected data improves by incorporating input from various disciplines. This, in turn, leads to better decision-making about product safety.
Organizations we work with that implement Regulatory Intelligence within their pharmacovigilance function report increased efficiency and improved decision-making.
Outsourcing Regulatory Intelligence for Pharmacovigilance to a CRO
Outsourcing Regulatory Intelligence for pharmacovigilance to a CRO can be an effective way to manage this vital process. A CRO specializing in regulatory Intelligence can help you stay up-to-date on the latest developments in pharmacovigilance and ensure that your program meets all applicable regulations.
In addition, a CRO can provide valuable insights into how new laws and regulations may impact your business. By outsourcing regulatory Intelligence to a CRO, you can focus on your core business while remaining compliant with all relevant laws and regulations.
CMC: Down the road in effective IND/IMPD writing
In the previous two articles, we have shared our experience on various aspects of effective IND/IMPD CMC writing, considering proper planning, assigning a dedicated CMC writing team, and having effective project management. In addition, we discussed technical writing particulars giving some key messages on document preparation. Now, we will discuss other important points. These are safety, data completeness, and geographical regions.
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.
How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?
It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments for such transitions. The value for M&A in the pharmaceutical sector was $221 billion in the first half of the year 2015. In 2019, the worth of pharma companies M&A activities have reached $357 billion.
CMC: Best Practice in Effective IND and IMPD writing
This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.
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.
CMC: Effective Writing of IND and IMPD
Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to start clinical investigations in humans. Furthermore, I will provide the key features and practical advice on how to deliver effectiveness. Firstly, we have to define the team in order to understand if the organization has capabilities to do CMC writing in-house or needs to outsource.
Biomapas appoints Head of Global Regulatory Affairs
May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution provider, with offices in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine, Poland and Kazakhstan, Biomapas continues to expand its international team and further increases capabilities for client-oriented solutions.
Regulatory Documents Translation Process – How to Ensure Consistency and Correctness
Mistranslation of regulatory documents such as a summary of product characteristics, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to serious consequences to a patient’s health. In 2007, as a result of inaccurate translation, 47 patients had badly implanted knee prostheses. An outer package labelled in English included different information.
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.
