Author: devadmin2

On Monday 28th January, Dr. Petracek will be on the panel for Session 5: Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics, with his topic being “Benefit-Risk Management of Recently Authorized ATMPs in the EU – Lessons Learned”.

On Tuesday 29th January, Session 8, Dr. Forstner will deliver a focused presentation “The European IV Iron PASS Consortium: Experiences from coordinating a multi-company, multi-registry PASS”.

DIA’s Pharmacovigilance and Risk Management Strategies Conference provides the context, background, updates, new developments, and future direction for regulations and guidance on safety, pharmacovigilance, and risk management strategies.

Program and registration details are available on the #DIAwebsite here. 

If you would like to set up a meeting with us during this event or have any other questions, please let us know by contacting us directly at marketing@primevigilance.com.

Ergomed’s PrimeVigilance is being recognised for the promising and transformative role that its robotic process automation (RPA) system plays in clinical drug development. As a thought leader, #PrimeVigilance has started early deployment of robotic process automation in pharmacovigilance. By 2020, automation is likely to reduce manual case processing efforts by over 80%. The system can increase efficiency by up to 400 times, increasing speed, reducing cost and improving accuracy in clinical trials. This positions Ergomed at the forefront of #pharmacovigilance services.
The awards ceremony will be held at the Hilton on Park Lane, London tonight.
Enquiries:
Ergomed plc Tel: +44 (0) 1483 503205
Stephen Stamp (Chief Executive Officer)
Numis Securities Limited Tel: +44 (0) 20 7260 1000
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black (Joint Broker)
Consilium Strategic Communications – for UK enquiries Tel: +44 (0) 20 3709 5700
Chris Gardner / Mary-Jane Elliott
Matthew Neal / Olivia Manser ergomed@consilium-comms.com
MC Services – for Continental European enquiries Tel: +49 211 5292 5222
Anne Hennecke
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 offering encompasses a complete suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand, in addition to a full range of high quality contract research and trial management services (CRO). Leveraging its CRO expertise, Ergomed also has a drug development portfolio of co-development partnerships and wholly-owned programmes. For further information, visit: http://ergomedplc.com

Dr Jan Petracek, PrimeVigilance CEO, would like to thank our numerous clients for entrusting PrimeVigilance with these appointments, and congratulates our hard-working staff for reaching this important milestone in our goal to become the global leader of pharmacovigilance and medical information services.
Please visit our QPPV page to learn more about our services, or contact us at marketing@primevigilance.com for any inquiries.

Signal Management in the European Union will be the key topic of his lectures, which aim to benefit professionals with basic knowledge and experience in #Pharmacovigilance or adjacent functions, such as PV Officers, PV Specialists, PV Experts, PV Coordinators, and Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.
If you fall into any of these categories and would like more information please visit the DIA website for a detailed agenda and registration details.
If you are interested in an on-site  meeting with Dr. Petracek or have any other questions, please let us know by contacting us directly at marketing@primevigilance.com .
The 5 days of training include a comprehensive overview of the core processes and systems in place and the latest news on the international harmonisation and standardisation activities in pharmacovigilance. Now available in individual Modules.

We do this by providing systematic risk minimization and faster insights into the safety and effectiveness of drugs to ensure patient safety and to meet evolving regulatory demands.
“The Primary driver for the need of pharmacoepidemiology is increased enforcement by regulators worldwide to generate pharmacovigilance real-world evidence,” says Dr Jan Petracek, CEO of PrimeVigilance and COO of Ergomed group.
PrimeVigilance’s new Head of Pharmacoepidemiology and Risk Management, Dr Michael Forstner, a well-known expert in this field, together with the team he has assembled, will be focusing on providing our clients with full services in these areas.
For more information, please visit our website new Pharmacoepidemiology section
or feel free to contact us at marketing@primevigilance.com

Philippe is a qualified pharmacist with over 15 years of experience in the healthcare and pharmaceutical industries. He has gained extensive expertise in clinical and medical affairs throughout his career, with leadership roles in successfully planning and executing multiple medical scientific programmes at local, regional and global level, including KOL relationship management, medical communications, medical education and medical information.
Philippe will be speaking:
Tuesday, June 26, 2018 at 2pm
• #257: Globalizing and Regionalizing Medical Information Contact Cente00rs
Wednesday, June 27, 2018 at 2pm
• #364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels
Programme and registration details are available on the #DIA website here.
If you have any questions or would like to connect with Philippe please contact us to set up a meeting or just stop by booth #1742 during the event.
For more information contact us at marketing@primevigilance.com
Overview:
DIA, founded as the Drug Information Association, has provided a global, yet neutral stage, for collaboration to address healthcare challenges for more than 50 years. DIA’s Global Annual Meeting (DIA 2018) gathers stakeholders from across the world to openly share knowledge, generating insights beyond boundaries to advance innovation in healthcare product development and lifecycle management globally.

He will be responsible for establishing a new revenue stream in this highly attractive premium part of pharmacovigilance, to meet the demands of our existing, as well as new clients. By this action, PrimeVigilance has met one of its strategic objectives.
Dr Jan Petracek, PrimeVigilance CEO, states, “The primary driver for the need of pharmacoepidemiology is increased enforcement by regulators worldwide to generate pharmacovigilance real-world evidence. This is closely linked with pharmacovigilance planning and risk management, which have now entered a new phase of maturity. As a result, with a vast majority of new products, and almost always when an important safety concern is identified, post-authorization safety and/or efficacy studies are requested by the regulator.”
Please, join us in welcoming Dr. Forstner to our fast growing company!
For any inquiries, please contact us at marketing@primevigilance.com.

This follow up webinar will provide an overview of the discussion taking place during this pilot period as well as some figures estimating upcoming workload. We are collecting feedback from regulatory inspectorates to better understand their standpoint with regards to the “grey zones” with highest impact on workload.
Key topics covered in this webinar include:

• What exactly needs to be considered during signal validations vs. further signal assessments?
• For which cases is it necessary to request L2B access?
• Whether to store these reports into safety databases.
• Are the expectations from generic companies any different?

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 Jan Petracek will be part of the Program Committee of the ICH Day Workshop: Pharmacovigilance and MedDRA, lecturing at two sessions focusing on ICH E2A and Practical Consideration on May 22. In addition to lecturing during the Pharmacovigilance & Safety sessions on Post Authorization Safety Studies and E2F Updates on Development Safety Update Reports on May 24th and 25th .
The 10th #DIA China Annual Meeting is a four-day conference which will bring together more than 2000 pharmaceutical R&D professionals from several continents and regions, involved in all levels of the healthcare product development spectrum, to discuss recent and upcoming transformational changes for China’s innovation and regulatory environments.
Program and registration details are available on the #DIAwebsite here.
If you would like to set up a meeting with Dr Petracek during this event or have any other questions, please let us know by contacting us directly at bd@primevigilance.com.

Martina Vlkova, MSc, PhD PrimeVigilance Associate Director, Head of QA, expert on pharmacovigilance and PV audits will lecture Portuguese pharma specialists in the latest news and best practices on the following topics:

• Pharmacovigilance and risk management of interventional and observational clinical research (Farmacovigilância e gestão do risco da investigação clínica intervencional e observacional)
• Case management and processing, expedited reporting (Gestão e processamento de casos, notificação expedita)
• Development Safety Update Report

This two-day pharmacovigilance training course is organized by the Ordem dos Farmacêuticos a professional public association that represents Portuguese pharmacists and regulates the pharmaceutical profession in Portugal.
PrimeVigilance services include organizing customized pharmacovigilance training courses for organizations, giving them the opportunity to receive strong pharmacovigilance support, much needed in our ever evolving industry.
If you have any questions or wish to hear more about our training services please contact us at bd@primevigilance.com.