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.
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.
May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution provider, with offices in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine, Poland and Kazakhstan, Biomapas continues to expand its international team and further increases capabilities for client-oriented solutions.
Mistranslation of regulatory documents such as common technical documents dossiers, a summary of product characteristics, labelling, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to serious consequences to a patient’s health. In 2007, as a result of inaccurate translation, 47 patients had badly implanted knee prostheses. An outer package labelled in English included different information.
April 2020 – Biomapas announced the opening of a new office in Central Asia. The new location in Kazakhstan strengthens Biomapas presence in the CIS region and further improves flexible and reliable clinical, regulatory and pharmacovigilance service delivery to the global life science industry in emerging markets. As a functional and full outsourcing solution provider, with a new office in Almaty, Biomapas continues to expand its international team and ensures the efficiency of services in 65 countries across 5 continents.
Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers (HCP), pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder (MAH). During the National semi-annual conference „Pharmaceutical News“ in Lithuania, State Medicines Control Agency representative delivered a presentation on the statistics of suspected adverse drug reaction (ADR) reporting in Lithuania.
March 2020 – Sebastien Duval joins Biomapas as Chief Business Officer to lead the business development department and extend Biomapas continued growth in the global life science industry. Sebastien Duval brings over 20 years of experience in the life science industry, previously acting as VP Sales Account Management at IQVIA, and further back in his career working as VP Business Development at Synteract, Executive Director, Global Head of Clinical Phase II-IV Business Development at QPS and as VP European Business Development at Premier Research.
Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.
March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.
February 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry Biomapas announced strategic growth in Warsaw. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and now in Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, with a new office in Central Europe Biomapas will strengthen its international team and geographical coverage of its services.