Biological and Biosimilar Medicinal Products

What is a biological medicinal product?

A biological medicinal product is a medicinal product that contains an active substance produced or excreted from biological sources (human, animal, or microbiological).

Due to manufacturing procedures and their origin, active substances of biological medicine shave significantly complex structure as compared to chemical active substances.

Some of the active substances of biological medicines may be found in human body, like insulin, growth hormone, or erythropoietin.

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All European Marketing Authorisation Holders are concerned by Nitrosamine Regulatory Actions

There is serious workload expected from all marketing authorisation holders (MAH) in EU! Let’s see what is expected for MAH compliance related to nitrosamines.

On 26 September 2019, the EMA published a statement titled “EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA/511347/2019)“. With regard to the Art. 5(3) referral, MAHs are requested to evaluate the risk of the presence of nitrosamine impurities in their human medicinal products containing chemically synthesized active pharmaceutical ingredients (“Information on nitrosamines for marketing authorisation holders: https://www.hma.eu/226.html”).  

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European "One-Stop-Shop" for Regulatory and Market Access Support

FarmavitaR+ is not only platform for on-line hiring of consultants, experts and freelances. We are also "one-stop-shop" for complex international projects.  To manufacturers of pharmaceuticals, biopharmaceutucals and medical devices, we offer "one-stop-shop" service across the 90+ countries worldwide.  

Our carefully selected team of local associates communicate daily with national regulators and payers at those matkets. This is the core of our business.

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Turkey - Growing Market and Pharmaceutical Hub 

As you all knew, at the end of July 2016, Turkey has suffered a failed coup attempt.   After that the government took some serious even excessive measures to clean the putschist or anyone related to these people from the state agencies. Around 80,000 personnel, working at the different agencies of the State were either fired or suspended. At the Ministry of Health, 115 senior director, 1504 physician, total 5581 personnel have been removed from duty.

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Conference: 10th - 11th March, 2020 (Warsaw, Poland)

PHARM Connect Congress

PHARM Connect Congress is the largest and most important pharmaceutical and biotechnology business summit in the Central Eastern European region, taking place annually in March. With its 500+ participants from over 25 countries in the region and beyond, the Congress – to be held for the tenth time on 10-11 March 2020 – is a great platform to benchmark and network with an exclusive group of senior peers. We are here to help and accelerate the effectiveness of your marketing strategies, maximise ROI and stay ahead of the competition.

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Conference: 14th - 15th September, 2020 (Toronto, Canada)

PHARMA COLLOQUIUM 2020

PHARMA COLLOQUIUM 2020 is an arena for interdisciplinary exchange among professionals in the fields of pharmaceutical technology and its related aspects. Pharma Colloquium 2020 incorporates about each stage of information, advancement, innovation and organizing; and has a target of making a worldwide gathering for academicians, specialists and business experts to discuss the soundest issues related to pharma, Biotech and Health Care.

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