Health information that has been posted online by patients can efficiently supplement your post-marketing drug safety data gained from traditional sources. Data harvesting from Social Networking Sites (SNS) has a lot of potential and significant advantages when compared to traditional sources. One of the main benefits is the near real-time monitoring of Adverse Drug Reactions.
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 even endanger the health and life of a patient. Thus, the main goal in medical writing, as in any writing, is to convey the message clearly and concisely.
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.
In July 2020 Biomapas started an EU funded project of research and development activities by creating an artificial intelligence (AI) tool for pharmacovigilance services. The main aim of the project – to create a pharmacovigilance system based on artificial intelligence. Biomapas plans to commercialize the prototype of the technology created during the project in the form of a new pharmacovigilance service which will ensure continuous improvement of drug safety.
With the growth of social media network users all over the world, there is no doubt that one of the most accessible and 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 (7). Therefore, since medical devices and over-the-counter medicines are being more and more often promoter by commercials on social media nowadays, there is greater risk of hidden or misleading advertisements (1).
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.
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.
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.
Medicine is constantly evolving to invent effective ways to treat diseases. This progress is a never-ending process: life science industry develops new molecules and treatments and improves existing ones continually. Experimentation and testing have long been a part of medicine, and it is up until now as clinical trials have an essential part in the development of new treatments. These reasons allow us to assume that the relevance of clinical trials will not diminish in the future.
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.