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.
Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships
The trend of outsourcing continues to grow in the life science industry. Global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018, and is expected to witness a compound annual growth rate of 11.9% over the period to 2026. Regulatory affairs outsourcing may vary in extent (from stand-alone service to full-scope solution), length (project based or long-term partnership with selected vendor), model (insourcing a dedicated expert for specific project or functional service provision), etc.
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.
Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch
In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When considering a switch, many factors like characteristics of market and population, local policies, advertising, confidence in regulatory authorities and other, influence the outcome. Though, the safety of patients has the highest priority. So, what questions should you ask?
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.
Biomapas appoints Director Regulatory Affairs
Ramune Rukiene joined Biomapas as Director Regulatory Affairs to further strengthen continued growth and geographic extension of Biomapas. Ramune will play an important role by leading regulatory activities, ensuring highest service quality and maximizing the efficiency of medicinal and veterinary product placement into the market. Furthermore, Ramune will work together with the management team to set a regulatory affairs strategy and to deliver unmatched service experience and quality in the market.
The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency
The IDMP is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238 (substances), ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). – which are being refined and implemented by regulatory bodies.
Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective
Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With the first quarter almost over, it is a great opportunity to look back and share the experience. The new requirements for safety features to appear on the packaging of all prescription medicines.
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.
Biomapas: Improving the Document Review Process
Biomapas currently covers 64 countries across Europe, CIS and MENA regions. Being able to provide clinical trial, regulatory affairs, medical writing and vigilance solutions to all of these countries requires us to have a large repertoire of native speakers on staff.
Since providing top quality work to our customers has always been of paramount importance for Biomapas, we needed a way to ensure document accuracy, and therefore decided to look at proofreading software to help us maintain quality.
Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?
Compliance with high quality standards is a non-negotiable performance parameter in Pharmaceutical and Medical Device industries. During 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485 implementation into BIOMAPAS Quality Management System was initiated. We discussed the influence of current changes to the whole company and its quality management with Egidija Pauriene, MD, Quality Assurance Director.
