Author: devadmin2

For the Excellence in Service Award: Awarded to the “Member of the Year” who has consistently provided outstanding service as a DIA volunteer, and who has contributed to the advancement of DIA’s mission.
This is an incredible achievement, which is a result of the many years of dedication to the advancement of global health, as well as his direct contributions to DIA.
For more than 50 years, #DIA (the Drug Information Association), a non-profit association, has served as a global forum for all those involved in health care product development and life cycle management to exchange knowledge and collaborate in a neutral setting. DIA is an essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation. Today, DIA is a worldwide organization in more than 80 countries with regional offices covering the Americas, Europe, Asia, the Middle East, and Africa.
If you are attending the DIA EuroMeeting 2018 in Basel, do stop by our booth #43-44 to meet  Dr Petracek and the rest of the Team.
For any questions, please contact us at marketing@primevigilance.com and for more information about the DIA EuroMeeting please click here.

“Intelligent Automation is building momentum across various industries, and the prospect of a digital workforce being the new normal, is fast becoming reality. Having had first-hand experience of the transformation across the financial industry, Intelligent Automation is already changing the workforce landscape across many of the large organisations, and the same principle is being implemented across the pharma industry. It is no longer a case of will it happen but that it is already happening…
Last year, the International Society of Pharmacovigilance held a thought provoking seminar – Intelligent Automation in Pharmacovigilance. Offering a unique, highly focused, scientific and interactive two-day event, hosted by Biogen at the Biogen Auditorium in Boston, Cambridge. 30 speakers across the pharma and technology services industry, were invited to speak on this hot topic, and the feedback gathered from the attendees at the seminar was very positive. Sparking some interesting, engaging and, at times, controversial debates during the open panel discussions. Due to popular demand, the seminar will be repeated later this year 2018.
Over the past couple of years, Intelligent Automation has been in the spotlight, with Robotic Process Automation (RPA) being one of the most talked about emerging technologies. But what is RPA? – RPA is a technology that uses the software to operate applications, allowing employees in a company to configure the computer software to execute tasks automatically. This technology captures the interaction between user and systems, to interpret existing applications for processing transactions, manipulating data, triggering responses and communicating with other digital systems. And the robot is a software application, that replicates the actions of a human being, interacting with the user interface of a computer system. Currently, the RPA logic mainly being used is rule-based and the robot processes are most effective on high volume repetitive tasks.
The pharma industry is full of daily repetitive tasks, that are currently being executed manually, and these processes are ideal for being executed by RPA. There are many advantages for companies to adopt the use of this technology such as, RPA will enhance continuity – a robot process can cover 24 hours per day; 7 days per week; 365 days per year (the only exception is for system housekeeping and maintenance on the robot). This allows organisations the opportunity for repurposing staff on complex tasks that require in depth analysis and decision making, adding much greater value for the company. It will also strengthen overall job satisfaction, as employees should feel more engaged, working on new and challenging assignments, leading to less staff turnover. And reducing time spent recruiting, interviewing and hiring; relieving the additional strain on key subject matter experts having to laboriously train new joiners to the company, and decreasing the need for overtime hours. All these factors should consequently help to develop a strong stable workforce, by potentially achieving the most important aspect of a work-life balance. RPA also increases quality assurance and compliance for the company, through consistency – the robot will always follow a certain process flow and will not deviate from the specifications, producing a very detailed audit log of all the actions being executed, thus facilitating audit requirements.
One of the biggest benefits for using Intelligent Automation in pharmacovigilance is being able to process and analyse vast quantity of data. This can potentially equate to faster detection of safety issues, as opposed to the slower manual conventional methods. The volume and diversity of regulated safety data to be screened, compiled and analysed by regulators and licence holders has been steadily increasing over the years, and is anticipated to further increase, implying the need for resources to a problematic extent. Intelligent Automation has potential to provide much higher efficiency and, at the same time, can be more cost effective in the long run.
So, back to the original question: “Is Intelligent Automation a game changer?” Looking at how the future of technology is shaping, ultimately the organisations that embrace and harness the full capability of Intelligent Automation will be the ones that are still in the game.”
For viewing the full article please visit Pharmafocus, and for any information please contact marketing@primevigilance.com

Key topics covered in this webinar include:
• How to plan signaling frequency
• What sources of data need to be considered
• What best to focus on during signal detection vs. signal evaluation reviews
• The robust documentation of activities
Finally this webinar will focus on giving the listeners a comprehensive overview of all the new regulatory requirements for products on an additional monitoring list, and some last-minute additional requirements for other products that were not expected to be impacted by EVDAS during 2018.
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.

This 2-day conference will be held in Canberra, Australia on 15-16 March 2018.
It will address the specific needs and interests of people working in the field of pharmacovigilance, either in regulatory agencies, pharmaceutical companies, academia, hospitals or community settings. The programme will cover topical pharmacovigilance and risk-management issues both internationally and in the context of the Australian and New Zealand health systems and particularly the specific situation of rapidly growing countries and health economies.
The second part of the course will focus on approaches to risk management and minimization. Participants will gain hands-on experience in development of Risk Management Plans (RMPs) and the conduct of benefit-risk assessments and how they should be adapted to local settings.
Preliminary Programme and Registration forms are available on the ISoP website at the following link to ISoP webpage
If you are interested in an on-site meeting with Dr Petracek, we will be glad to arrange it for you. For this and any other questions you may have, please contact us.

This seminar was the first of its kind worldwide to cover this complex development area, with over 30 speakers from some of the most influential companies in pharmacovigilance automation who presented their state of the art technologies and examined the disruption expected within the industry.
Some of the participating bodies included: AstraZeneca, Bayer, Biogen, Celgene, Genentech, Takeda and the FDA and the MHRA. Jan presented the results from its successful pilot project demonstrating how robotic process automation of selected pharmacovigilance systems can increase efficiency by up to 400 times, increasing speed, reducing cost and improving accuracy. PrimeVigilance is looking forward to the next leap forward in technology for our industry and our next seminar about this hot topic.
For more information and any questions please contact us at bd@primevigilance.com 

The DIA has prepared a very interesting PV training autumn program in Paris. “Pharmacovigilance in Paris” Training Weeks! 6 Pharmacovigilance trainings all in one location.
Gain tangible tips all in one place OR bring your team to divide and conquer. Courses include: Signal Management – Helping You Detect, Triage, Evaluate; Risk Management Plan Creation – Effectively responding to regulatory requests; and Benefit-Risk Management – Example that can kick-start your own processes.
Dr Jan Petracek will be participating as a trainer in the EU- RMPs Creation, Medical Writing of Periodic Safety Update Reports (PSURs/PBRERs), and Benefit Risk Management Pharmacovigilance training courses.
List of courses held at the Mercure Paris La Défense, Nanterre/Paris:

• Advanced Workshop: QPPV Tool Box – Your Key to Success | 13-14 November
• EU-RMP Creation |14-15 November
• Medical Writing of Periodic Safety Update Reports (PSUR/PBRER) |15-16 November
• Signal Management in Pharmacovigilance | 15-16 November
• Medical Approach in Diagnosis and Management of Adverse Drug Reactions | (ADRs) 28-29 November
• Benefit-Risk Management | 28-29 November

And for more information and registration please see the following DIA link

Phil will be speaking on Day 2 Nov 16, 2017 during the “Session 5: Vendor Engagement and Optimization” at 9 am for topic : “RFPs and Vendor Selection Process”, running a strategic discussion about how best for pharma to evaluate the benefits and detriments of out-sourcing, service providers by anticipating their needs when submitting an RFP.
For more information please contact us at bd@primevigilance.com.
Overview
The 11th year of the Annual European Medical Information and Communications Conference is a unique meeting organised by medical information professionals for medical information professionals. Each year, speakers share practical experience dealing with current issues and challenges in medical information departments. Participants are encouraged to take part in workshops and discussions within the sessions.
 

Key topics covered in this webinar include:
• simplified EV reporting requirements
• EV Access levels for MAHs
• non-serious cases
• downloading/processing ICSRs from EV
• increases in workload?
• importance of prompt updates to XEVMPD
• E2B R3 format – challenges of conversion
• changes to MLM case management
• which EVWEB registration status to choose
• SDEAs
Finally, she will outline some challenges of E2B (R3) conversions and pragmatic processing of all source data that is made available in E2B (R3) format in a safety database which operates with E2B (R2) format, and highlight the key considerations that can help streamline the process and meet the regulatory (GVP VI) requirements.
Ivana will also be available at the end to answer any questions you may have, offering you the benefit of her knowledge and experience.
Click here to book your place today. If you require further information, please do not hesitate to contact us.

Additionally, today we begin harmonizing our appearance within the Ergomed Group of companies. In reflection of our growth and modernisation our new logo reflects who we are today and symbolize our dynamic future with the introduction of new brighter, more dynamic, & modern colours.
We are proud of our history, that’s why our new logo retains our core red colour and added as dominant colours the newly introduced Ergomed Blue, together with a few secondary colours to accent and support the primary colour palette.
The PrimeVigilance logo comprises the name PRIMEVIGILANCE in the corporate font with the ‘circle’ device. This device is derived from the Ergomed logo and represents a stylized pie chart that is associated with the presentation of the results of researches.
We thank all our employees for their significant contributions to our company’s success and we strongly welcome our new logo and website.
For any information please contact:
Florence Denance-Habek,
Head of Marketing
florence.denance.habek@primevigilance.com

The 2017 APEC PV CoE Pilot Program will be conducted in Seoul, South Korea from September 13 – 14, 2017 at the BEST WESTERN PREMIER Seoul Garden Hotel.

About  the APEC Harmonization Center

The APEC Harmonization Center is established under the authority of the APEC Life Sciences Innovation Forum (LSIF). South Korea presented a proposal for a harmonization center, referred to as the AHC, at the sixth LSIF in August, 2008. The proposal included substantial self-funding from the Government of South Korea and was widely supported at LSIF. In November 2008, APEC Ministers specifically endorsed the AHC in their Joint Ministerial Statement: “Recalling our commitment to promoting regulatory reform and harmonization, we welcomed and endorsed the establishment of the APEC LSIF Harmonization Center in Seoul as a key step forward.”
For  more information and the program please visit the APEC website