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.
Regina Auskalniene, Head of Clinical Operations at Biomapas, was elected to lead Lithuanian Good Clinical Practice and Regulatory Affairs Association. The association unites middle size and global CROs in the Baltic countries and is focusing on creating the most efficient environment in Europe to deliver clinical trials. „Everyone in our association agrees that we can run much more clinical trials in the Baltic states, thus creating an attractive place for clinical research in the future,” said Regina Auskalniene.
The trend of outsourcing continues to grow in the life science industry. Global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018, and is expected to witness a compound annual growth rate of 11.9% over the period to 2026. Regulatory affairs outsourcing may vary in extent (from stand-alone service to full-scope solution), length (project based or long-term partnership with selected vendor), model (insourcing a dedicated expert for specific project or functional service provision), etc.
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.
In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When considering a switch, many factors like characteristics of market and population, local policies, advertising, confidence in regulatory authorities and other, influence the outcome. Though, the safety of patients has the highest priority. So, what questions should you ask?
Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).
PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.
Ramune Rukiene joined Biomapas as Director Regulatory Affairs to further strengthen continued growth and geographic extension of Biomapas. Ramune will play an important role by leading regulatory activities, ensuring highest service quality and maximizing the efficiency of medicinal and veterinary product placement into the market. Furthermore, Ramune will work together with the management team to set a regulatory affairs strategy and to deliver unmatched service experience and quality in the market.
The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions.
The IDMP is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238 (substances), ISO 11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging) and ISO 11240 (units of measurement). – which are being refined and implemented by regulatory bodies.
In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.