GRIP - The Global Regulatory Intelligence Club for Pharmacovigilance
Need a better way to do regulatory intelligence for your pharmacovigilance (drug safety) operations?
Join the club.
The Global Regulatory Intelligence Club for Pharmacovigilance is a unique offering, consisting of a comprehensive collection of global requirements "rules" that have been collected and analyzed by our pharmacovigilance experts - we "crowd-source" the truth by having the members of the club provide their view-points. Then it is also a networking opportunity, specifically for Pharmacovigilance professionals that are involved in the value-chain of identifying, assessing and implementing requirements.
Subscription to the club is easy. And will jolt you forward
We have done our best to make it easy. Subscribers receive:
Access to all global PV requirement documents and associated actionable rules (currently covering 157 countries)
An online PROHALO environment, where these rules can be easily accessed, searched, sorted, filtered, listed and exported. (If your company already has HALOPV or PROHALO, we will load any additional requirements into your current environment for you)
Ongoing invitations to networking opportunities in the club as well as continuous dialog with our experts
What does a subscription cost?
The pricing is simple. The subscription comprises of a PROHALO subscription and a Regulatory intelligence service. The total costs are as a low as 4,000 EUR / USD per month.
The club is open and we are ready to receive your request for membership.
See the list of planned event in the club on the Insife Event overview
Sign-up for your membership by sending us an email here
4 reasons why do we need regulatory intelligence in the PV space?
Pharmacovigilance (PV) is heavily regulated and often scrutinized by the public. Increasingly so after COVID-19
PV is considered a license to operate – with heavy impact for mis-conduct
PV is (still) rapidly changing across the globe – and local flavors are very prevalent, despite ISO, ICH, CIOMS and other organizations' attempts to standardize the requirements
In fact, PV has been overrun by changes in regulations for two decades - The deep focus on “license-to-operate” impairs other initiatives
What past experience tells us about the process...
Keeping up with regulations is hard work
...even with traditional sources to assist the data collection it takes multiple full-time employees to maintain a global overview
HQ / Affiliate alignment can be a challenge – who owns the process and owns the single source of truth? Often, decisions are made to HQ own all the regulatory intelligence data, despite affiliates being closer to the local agencies
Getting actionable intelligence
Changing regulatory documents into actionable rules that e.g. The safety database technical team can implement is a major hurdle
›Have seen examples from Industry where regulations took more than 6 months to implement into safety database after understanding the updates needed
It can be difficult to understand if a requirement is truly implemented globally.
GRIP - a new way of working with regulatory intelligence
We all do a lot of the same work! Why not lift it together and do it smarter?
The Global Regulatory Intelligence Club for Pharmacovigilance is a unique combination of technology, multi-sourced intelligence and networking, specifically for Pharmacovigilance professionals that are involved in the value-chain of identifying, assessing and implementing requirements.
Want to know more, get a demo or take it for a test drive?
We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. Just email firstname.lastname@example.org.
We look forward to working with you.