Letter of Agreement between CICE-Carleton University & Tenet Health Edutech Pvt. Ltd., India

                                                             

Letter of Agreement between CICE-Carleton University & Tenet Health Edutech Pvt. Ltd., India

The Canada-India Centre for Excellence (CICE) at Carleton University and THEPL have partnered to offer a suite of professional development courses, collaborative research projects and other capacity building initiatives to be delivered in Canada, India, and blended online delivery models. CICE’s current and future professional development programs will be eligible for delivery in India under this partnership. CICE will be responsible for the delivery of the programs while Tenet will be responsible for marketing the programs and providing adequate infrastructure on case by case basis to successfully deliver the programs.

With this partnership, CICE and THEPL have agreed to implement the following:

·        * Programs for the governments, both central and state

·       *  Corporate training programs for private sector and public sector companies

·       *  Industry specific training programs for companies

·       *  Pharmaceutical quality assurance and regulatory affairs training

·        * University / college groups for programs both in Canada and India

·     *Specialised Certificate programs to be delivered in India through live webinar/videoconferencing     sessions from Canada (not valid for any immigration purpose)

·        * Research and consultancy projects

*Training programs would be promoted through www.eduminds.in and www.cliniminds.com. To promote research and consulting services projects www.thinki.in and www.mediminds.com

For more information, please contact +91 98100 68241 or info@cliniminds.com; bd@eduminds.in

Cliniminds Association with Amity University for Faculty Development Program

Cliniminds – Leading Institute in Clinical Research & Pharmacovigilance Training proudly announces its Association in Faculty Development Program for Amity Institute of Pharmacy , Amity University.

For further queries Kindly Contact us at :
info@cliniminds.com or 91-9810068241
Visit our Website : www.cliniminds.com

Cliniminds- Leaders in Pharmacovigilance Corporate Training

Cliniminds was recently engaged in providing corporate training to one of the leading IT Company who are pioneers in providing pharmacovigilance software solutions. Our training was conducted through online learning mode, we had participates connected with us globally (Europe, Japan and India). 

The training involved a series a 15 sessions which focussed on key areas of pharmacovigilance like, MedDRA, Case processing, Medical review of ICSR, Aggregate reporting, Signal detection, E2B submissions, Vaccine safety, Quality assurance and, were conducted by a panel of subject matter experts from leading pharmacovigilance organization.

The training involved online assessments, case studies and practical session to gauge each participant’s performance. We also ensured that our participants were provided with hard-copied printed books and online access to our content which included PowerPoint presentations and research notes.

The training program was concluded with final assessment upon the completion of which each participant was awarded with Advanced Post Graduate Diploma in Pharmacovigilance accredited from ACCRE, USA

CLINIMINDS -accredited from ACCRE, USA, has been on forefront in providing corporate trainings to leading pharmaceutical clients and has been awarded as the Best Clinical Research & Health Sciences Business Management Institute consecutively for six years - 2011, 2012, 2013, 2014, 2015 and 2016 by leading agencies including ASSOCHAM.

For more details contact us at +91-9810068241; info@cliniminds.com or visit us at www.cliniminds.com

Audit Contingency & Form 483

We have quite often heard about the contingency plan for an Audit, especially when it is a regulatory inspection, like by the US FDA (United States Food and Drug Administration) or MHRA (Medicines and healthcare product regulatory agency). 

Claris recently underwent a regulatory inspection by the US FDA and was given the green flag with no observations reported.

With compliance being the utmost priority for every inspection, It has become essential for every Marketing Authorization Holder (MAH) to have an audit response team, which would capable and qualified to understand all the norms and requisites for a regulatory visit.

Over the past several years it has been observed that FDA has been proactive in constantly monitoring ADR and compliance which has led its issuing of ‘Form 483 warning letters and citations’ to many companies. 

Form 483 refers to the 21 United States Code (USC) part 374 which authorizes US FDA to conduct ‘Inspectional observation’ and ‘Factory Inspection’, It is therefore ideal that every MAH should have an SOP on inspection readiness for both regular and targeted audits.

We at Think I are also engaged in providing training in Quality Assurance, Audits and Inspection. Our team comprises of seasoned subject matter experts from pharmacovigilance Industry.

We provide Pharmacovigilance safety solutions using cloud based technology which are not only cost effective and user friendly but also fully validated meeting all the compliance checkpoints facilitating  quick, easy import, entry and electronic submissions of adverse event. 

For more details, contact us at +91 9560102587, +91 9810068241 or 

email us at medical@thinki.in or simply visit www.thinki.in

Joseph Mathew

Sr. Manager-Think I

Drug Safety and Brexit

There have been talks about what would happen once UK leaves EU which has put lot of QPPV (Qualified Persons Responsible for Pharmacovigilance) in UK in dilemma as the regulations say that the QPPV should be a part of the EU, with the impact Brexit it will hit the pharmacovigilance system in UK as EU would not be obliged to carry out Post marketing surveillance in UK.

Currently June Raine who is chairing the Pharmacovigilance Risk Assessment Committee ( part of the European Medical Agency, in which there are two members from each member state) is from the Medicines and healthcare products regulatory agency (MHRA) of the UK.

There have been discussions about QPPV who still want to be a part of EU which might eventually lead to a negotiation between EMA and UK to collaborate pharmacovigilance activities together, as pharmacovigilance is above politics.

By Joseph Mathew

Sr. Manager- Think i

About us:

We are an organization providing technological solutions and result oriented quality services in Pharmacovigilance, Clinical Trials, Medical Writing, Drug Regulatory Affairs and Human Resources.

We provide cloud based software solutions for pharmacovigilance which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event. 

For more details, contact us at +91 9560102587 or +91 9810068241

Email: medical@thinki.in ; www.thinki.in

The ‘new’ EUDRAVIGILANCE

European Medical Agency would be releasing a new version of EudraVigilance system, which is expected to go live in November 2017, EMA in their report mentioned that they would be publishing a checklist of readiness for all the stakeholders to prepare them for the changes which will come along with the launch of the revised version of EudraVigilance, for which EMA also intends to provide eLearning modules, support webinars and face to face training.

The prototype of EudraVigilance test environment or XCOMP is already scheduled to be released June 2017 which will let all the National competent authorities to test Individual case safety reports in E2B R3 versions.

We at Think I are also driven to produce Pharmacovigilance safety solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event. 

For more details, contact us at +91 9560102587, +91 9810068241 or email us at medical@thinki.in or simply visit www.thinki.in

Joseph Mathew

Sr. Manager-Think I