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Saudi FDA’s New Pricing Guidelines and Impact on the Region

By | news1

In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.

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Expediting access through Reliance Pathways: MENA region

By | news1

Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities. Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.

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eCTD implementation across MENA region: What is the current status?

By | news1

As the electronic Common Technical Document (eCTD) has become the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is the situation in the Middle East and North Africa (MENA) region and what other dossier formats are accepted there?

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Drugs serialization and barcoding in Saudi Arabia and MENA region

By | news1

An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. Are these regulations also required in Saudi Arabia and what about the whole Middle East and North Africa (MENA) region? What to expect if you serve these markets?

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3 Factors Affecting the Successful Collection of Drug Safety Information in Social Networking Sites

By | news1

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.

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Migle Janeliuniene

Building Health Literacy: The Value of Good Writing

By | news1

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.

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CMC: Down the road in effective IND/IMPD writing

By | news1

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.

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European Union Funding/Europos Sajungos parama

By | news1

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.

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Proper Publicizing in CEECs – Path to Successful Social Media Commercials

By | news1

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.

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Igne Pleskute, MPharm Regulatory Affairs Specialist Biomapas

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

By | news1

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.

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