On behalf of Oviya MedSafe, I am glad to extend our warm greetings and hearty wishes to you and your family for the festive Christmas and New Year season, through this December 2013 edition of Oviya MedSafe's newsletter!
We are happy to highlight Literature Search & Review, as Oviya MedSafe's featured service of the month. Oviya MedSafe offers weekly literature search services for marketed products, both in real-time and retrospectively, either as an addition to any of our drug safety services or as standalone support to an existing pharmacovigilance department of a pharmaceutical company.
At Oviya MedSafe, on-going product surveillance is carried out competently to manage high hit rates efficiently and effectively. The search results are screened by qualified staff and the individual cases are tracked through a workflow process which facilitates prompt expedited reporting and ensures a complete audit trail. Whenever cases need to be expedited to regulatory authorities, we order published articles and arrange translations on behalf of our clients.
We present a brief overview of the most important literature monitoring regulations in the European Union (EU), as follows:
• European Medicines Agency (Agency) shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances;
• Marketing Authorization Holders (MAHs) shall only submit Individual Case Safety Reports (ICSRs) published in scientific and medical literature for those journals and active substances not monitored by Agency;
• Until the lists of journals & active substances are published by Agency, MAHs should monitor all their active substances by accessing widely used systematic literature review and reference databases.
The exceptions for not reporting ICSRs are:
• Where ownership of medicinal product by MAH can be excluded based on active substance name, formulation, route of administration, primary source country or country of origin of reaction;
• Reports from literature articles presenting summary data analysis from publicly available databases or detailing patients in tables or line listings;
• Reports from literature articles based on analysis from National Competent Authorities (NCAs) databases in the EU.
On the events front, Oviya MedSafe will be represented in two events which will be happening in short succession at Bangalore. I have been invited to speak on Medication Safety at IPSCON 2013, the 46th Annual Conference of the Indian Pharmacological Society to be held at Bangalore between 16th and 18th of December 2013, with pre-conference workshops on the 14th and 15th. I take this opportunity to invite you to this scientific feast which offers 13 symposia, 6 pre-conference workshops, 19 plenary lectures, 5 prize paper sessions, oral & poster sessions and exhibitions to the delegates. I believe that this conference will also provide a unique opportunity to network with eminent pharmacologists and researchers across academia and industry from around the world.
As an Executive Committee Member of the Indian Society for Clinical Research (ISCR) and on behalf of the Local Organizing Committee of the 7th Annual ISCR Conference, I take great pleasure in inviting you to participate in the conference which is to be held on 10th and 11th January 2014 at Bangalore. This prestigious annual conference is expected to see high number of participants from the Clinical Research industry (CROs and Pharmaceutical companies), Academia, Regulators and other associated stakeholders. The 2 day-conference is planned so that latest updates on clinical research as well as the evolving regulations are discussed and deliberated by experienced and expert faculty from across India as well as invited speakers from outside India. Please click here for the details of the conference, including the scientific programme and the online registration system.
I thank you for your patient reading and look forward to meeting you at Bangalore between 16th and 18th December 2013 and again on 10th and 11th January 2014.