This report showcases the country’s most inspiring and fast growing small and medium-sized companies.

To read more about Ergomed and download the UK report here

Randomized controlled trials (RCTs) remain the gold standard for establishing the causal relationship between medication treatment and outcomes.

However, for some clinical questions, RCTs may be unethical, infeasible, too costly, and/or lack generalizability beyond a very narrow population only. In these cases, alternative study designs are crucial for supplementing the evidence from RCTs and providing required information on the comparative effectiveness and safety of medications.

Pragmatic studies and observational studies collecting and/or assessing real-world data (RWD) can supplement the evidence from RCTs and provide required information on the comparative effectiveness and safety of medications. However, concerns about the validity of real-world studies continue to detract from their utility for decision-making.

In this webinar, we will summarize key considerations – study design, methodological approach and tools – which stakeholders should consider when designing or evaluating real-world studies. All portrayed along with practical case examples of studies.

We will be discussing:

• How to decide on best real-world study approach to use: study design algorithm
• Methodological challenges and solutions of various real-world study approaches
• Case examples of real-world studies

The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty. 

Click here to book your place today. If you require further information, please do not hesitate to contact us.

 

At ESPID 2019 Maartje will have 2 oral presentations of her work in respiratory syncytial virus (RSV).
May 06-11, 2019 | Ljubjana, Slovenia

The 37​th Annual Meeting of the European Society for Paediatric Infectious Diseases #ESPID2019 will feature a wide range of sessions and learning opportunities showcasing the latest research and developments in the field of Paediatric Infectious Diseases worldwide, hosted by leading international experts.

For more information, please visit ESPID website

In addition, at ISPOR 2019 Maartje will run a forum and have a poster presentation the following week
May 18-22, 2019 | New Orleans, LA, USA

In the poster presentation, Maartje will be describing global trends in the secondary use of health data in post-marketing studies.

In her forum, she will present the newly proposed ISPOR Real World Evidence (RWE) Special Interest Group (SIG). The #ISPOR RWE Special Interest Group (SIG) is dedicated to increasing awareness, understanding, rigor and utilization of #RWE as an important part of the wider evidence base for healthcare decision-making.

The poster presentation will be May 22nd and the forum will take place on Tuesday, May 21st from 12:30 PM to 1:45 PM.

For more information, please visit ISPOR website

If you plan to attend ESPID or ISPOR and have, any questions on the research or any other questions feel free to reach out to set up a meeting with Maartje and contact us via marketing@primevigilance.com

Dr. Petracek shared his experience and knowledge on three topics: ICSR Assessment plus a Case Study, Benefit Risk Assessment through Product Lifecycle plus lead a Group Discussion about how to Evaluate Appropriate Risk Management Plan. By sharing his knowledge and experiences, Dr Petracek is hoping to help tackle current and future challenges in health products regulation.

This CoE was set up with great support from the APEC Regulatory Harmonization Steering Committee (RHSC), the China National Medical Products Administration (NMPA), Peking University, and related government agencies and industry organizations, to 1) promote regulatory convergence (harmonization), capacity and cooperation for health related products; 2) to leverage the development of guidance and criteria in regulatory sciences in China. As part of Peking University, the CoE provides a neutral academic platform for regulatory stakeholders to come together for the sharing of knowledge and experiences in tackling current and future challenges in health products regulation.

For more information and the program please visit the APEC website

PRESS RELEASE

London, UK – 23 April 2019: Ergomed plc, (LSE: ERGO) (‘Ergomed’ or the ‘Company’), a company focused on providing specialised services to the pharmaceutical industry, today announces that PrimeVigilance, its pharmacovigilance, regulatory and medical information service provider, has been awarded the Queen’s Award for Enterprise for the second time reinforcing PrimeVigilance’s broad leadership position as a provider of contract pharmacovigilance, regulatory and medical information services. Now in its 53rd year, the Queen’s Awards for Enterprise are seen as the most prestigious business awards in the country.

PrimeVigilance has received the 2019 Queen’s Award for International Trade in recognition of its year-on-year outstanding services to a pharmaceutical, biotechnology and medical device companies across its global customer base. As an International Trade winner, PrimeVigilance has demonstrated substantial growth in overseas markets and commercial success, further cementing its place as a global leader in pharmacovigilance and the collection of Real World Evidence data.

PrimeVigilance first received a Queen’s Award for Enterprise in 2014 in recognition of its substantial growth and commercial success and this second award recognizes the outstanding contribution played by the dedicated professionals that partner with and support PrimeVigilance’s clients.

In addition to pharmacovigilance, Ergomed provides full CRO services across all phases of clinical development and therapeutic areas under the Ergomed brand, with a particular focus on orphan drug development.

The global pharmacovigilance market is forecast to grow to more than $8 billion by 2024 from around $3 billion in 2015, with contract outsourcing forecast to expand from around 30% of the market in 2015 to approximately 50% in 2024. (Source: Global Market Insights 2017.)

Dr Miroslav Reljanović, Executive Chairman of Ergomed, commented: “We are delighted that Ergomed’s PrimeVigilance has been honoured with a Queen’s Award for the second time in recent years. This prestigious accolade recognises the Company’s continued year-on-year international growth and reinforces Ergomed’s position as a leading provider of services to the pharmaceutical industry, but more importantly it is testament to our excellent people and their valuable contribution towards improving the lives of patients.”

Dr Jan Petráček, Chief Executive Officer of PrimeVigilance, commented: “We are excited at being awarded this prestigious award again. It reflects the excellent teams here at Ergomed’s PrimeVigilance. The vital work performed by our professionals in support of the pharmaceutical industries is really helping to improve patient’s safety and outcomes and it is this professionalism that drives our continuous development. Every day in every way we are getting better and better.”

Enquiries:

Ergomed plc : Tel: +44 (0) 1483 402 975

Miroslav Reljanović (Executive Chairman, Ergomed plc )
Roy Ovel (Chief Commercial Officer, Ergomed plc)
Jan Petráček (Chief Executive Officer, PrimeVigilance)

About Ergomed plc
Ergomed provides specialist services to the pharmaceutical industry spanning all phases of clinical development, post-approval pharmacovigilance and medical information. Ergomed’s fast-growing, profitable services business includes an industry leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand, and a full range of high-quality contract research and trial management services under the Ergomed brand (CRO), and an internationally recognised specialist expertise in orphan drug development, under PSR. For further information, visit: http://ergomedplc.com and https://primevigilance.com.

For more information, please contact:
marketing@primevigilance.com

PrimeVigilance with over 75% of its workforce being women says a big THANK YOU to all the wonderful and amazing women in the organisation for their dedication and support, helping our company reach its goal to become leader in its industry and for choosing PrimeVigilance to be part of your individual professional success story, thank you Ladies!

This session takes place on Thursday 14th of March 2019 starting at 3 pm GMT (UK), 4 pm CET (Europe), and 11 am EDT (US).

During this webinar, PrimeVigilance’s expert speakers will describe the EMA/FDA ambition for greater use of real-world evidence (RWE), present several case examples of RWE use in regulatory submissions and beyond, and discuss what a future in which patient-centric RWE is commonly used might look like.

This webinar will discuss the following:

• First, we will set the stage by briefly describing the current RWE regulatory landscape in the EU and US.
• We will then present several case examples of how RWE has been used in regulatory submissions and post launch.
• Finally, we will describe what may be forthcoming, namely that generation of safety and effectiveness data outside of clinical trials will continue to develop from a single-source, passive system to an evolving holistic approach based on multiple data sources and study designs. This would allow for a new era in which post-approval effectiveness and safety are predicted on sophisticated analysis of likely benefits and risks prioritised for interrogation. In addition, patient-centricity, collaborative trial design, and technological developments may gradually allow us to shift some studies and data collection to the point of care and the patient home setting, making the development of actionable evidence more efficient.

The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty. 

Click here to book your place today. If you require further information, please do not hesitate to contact us.

Dr Forstner will be giving a short course with the featured topic “Pharmacovigilance – Benefit-Risk Management Methodologies” on Monday the 4th of February 2019 at 2pm. The DIA Europe is more than a traditional meeting. It’s a chance to learn and engage as a healthcare professional alongside thousands of cross-functional collaborative leaders.

Dr Forstner’s focus areas are the planning, development, implementation, and evaluation of benefit-risk management solutions, as well as the optimisation of processes around benefit-risk management. In addition, he is highly engaged in developing and applying (benefit-) risk analysis methodologies in order to make RM planning more formally reproducible.

For further information and details, please contact us at marketing@primevigilance.com or visit the DIA website for the programme and registration by clicking on the following link