The intersection of AI and Medical writing: a new era

AI is again at the forefront of everyone’s mind. Though a groundbreaking technology, it remains controversial. A few facts remain constant whether you are pro or against using AI. It is here to stay and will be implemented in many different facets of life. Take a journey with us and learn about AI and all the tools that exist thus far in the medical writing domain. Uncover how this technology is empowering medical writers and what the future may hold with coming improvements. Spoiler: AI does not replace medical writers.
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Dossier submission to Health Authorities (ESG, CESG, CESP, EMA Gateway, MHRA)

We sometimes think that publishing a CTD sequence is the final step in the process. Just an important is the submission of that sequence. Especially when avoiding invalidation and slowing down the entire process. For this reason, publishers must also be trained in the different submission portals according to the regions where they are being submitted. Take a quick dive with us and learn about Dossier Submissions to some of the more popular Health Authorities and the different submission portals they use to accept published documents.
Learn all about the dossier submission here

Orphan drug designation for marketing

We are seeing a significant rise in the number of Orphan drugs being developed and brought to the market recently. Some pharmaceutical companies are heavily focusing on this niche market as significant benefits are being offered to develop these drugs and fight these diseases. That being said, specific regulations govern the development of these medicines. These regulations are not always easily understood, and many individuals and companies struggle to navigate them successfully. Take the time to read through our article on Orphan drug designation for marketing to understand some of the necessary criteria and benefits of developing an Orphan drug.
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Innovative approaches to animal testing

Animal testing has long been the standard for experimenting with new drugs. It has always been a controversial topic based on ethics, accuracy, and cost-effectiveness. But we can all admit it is how most medicines have been created throughout human history.
As the medical field continues to evolve, they are seeking new and innovative methods to avoid animal testing improve accuracy, and cost-effectiveness of experimentation. Several techniques have been created over the years, and they are becoming more widely adopted in the industry. See the new techniques being pioneered and how they can be applied to the next product you’re thinking about developing.

Dive into innovative approaches here

How to improve data quality during a RIM Implementation

Implementing a RIM can be a daunting task. There is much planning that goes into such a huge project. However, it does provide a unique opportunity to improve the quality of your data before the implementation. If you did not have data governance before, this would be the time to define and integrate that aspect. Data cleaning and enrichment are also now on the table, as you may not have had a chance to do so previously. RIM, as a solution to manage your regulatory information, can also benefit you in other aspects of data management.

Learn how here

Specific regulations/requirements of international markets

Many different markets exist within the global pharma landscape. Over time, these markets have become agglomerated utilizing specific criteria. Two main categories within the pharma space are regulated and international markets. While these are not the only two globalized markets to exist, they are undoubtedly some of the more common ones that companies recognize. Subtle differences exist in these two sectors depending on geography and history. Based on these facts, pharma companies employ various strategies to capitalize on these different criteria to register their products and grant access to medicines globally. Journey with us to understand some specific regulations in the international market and how they differ from the regulated markets.
Read our insight here

Local literature and global literature in pharmacovigilance: bridging the gap for safer medication use

Literature search has always been a key component to maintaining the safety and efficacy of medicinal products. However, we admit it sometimes needs to get the attention it deserves within the portfolio of processes regarding pharmacovigilance. The literature search contains two sub-categories, local and global, and they work in tandem to provide critical data in decision-making. We want to share some significant differences between these two types of searches, why they are equally important, and how their integration contributes to the bigger picture regarding medicinal safety.
See how PLG support your needs internationally

Differentiating safety data exchange agreements (SDEA) and Pharmacovigilance Agreements: ensuring patient safety and regulatory compliance

Terminology plays a considerable role in how things are named, how we understand functions, and how we communicate. The more technical fields have precise nomenclature and terminologies to describe everything specifically. The pharma industry is no different. It may seem like semantics, but knowing the correct terminology can save individuals from miscommunication, costly mistakes, and life-threatening errors when dealing with medicines. We will discuss the differences in the terms of the Safety Data Exchange Agreement (SDEA) and Pharmacovigilance Agreements. You may think they both mean the same thing, but have some significant differences. Knowledge like this can save you a lot of time when negotiating with multiple stakeholders.
Understand those two types of agreement

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January 2024 Monthly Newsletter