Dear Well-wishers,

As I begin this September 2018 edition of Oviya MedSafe’s newsletter, I am excited to share with you about two distinct professional privileges the month gifted me with, which I believe will have far-reaching impacts on my thought processes for a better pharmacovigilance scenario in India, from the perspectives of regulatory compliance for industry and that of advocacy for public health respectively.

The first privilege was an opportunity to interact directly with the Indian Regulatory Authorities during a meeting called for by the Pharmacovigilance Division of the Central Drugs Standard Control Organization (CDSCO) on the subject of the ‘Pharmacovigilance System at Marketing Authorization Holders (MAHs) Site and Inspection‘. Leading an industry delegation, I presented the group’s views in this consultative meeting following which the Draft Pharmacovigilance System Inspection Guideline was unveiled. The document has been subsequently publicized and shall remain open for comments/suggestions from all stakeholders until 31st October 2018.

The second privilege was being chosen to moderate a panel discussion featuring the renowned Prof Bejon Misra among other distinguished panellists. I conducted this vibrant session titled ‘Perspectives on Pharmacovigilance Awareness & Challenges in India’ at the successful 5th Annual Pharmacovigilance Symposium of ISCR (Indian Society for Clinical Research) at Mumbai. Having played a leading role in organizing all of the five annual pharmacovigilance symposia of ISCR since 2014, I felt this honour to be a vindication of my passion for pharmacovigilance. The photographs clicked at the symposium may be viewed/downloaded using this link.

I had written at length about Oviya MedSafe’s specialized pharmacovigilance services for local affiliates of foreign multinational pharmaceutical companies, in our October 2016 newsletter. The edition highlighted how local affiliates function as strategic business units which carry out country-specific activities of the company, while ensuring that they are aligned with their global policies. The specific pharmacovigilance requirements at a local affiliate level were listed and Oviya MedSafe’s expertise in providing customized Indian local pharmacovigilance compliance support was emphasized. I wish to re-visit this focused sector of Oviya MedSafe’s offerings in the context of the recent developments in the milieu in India, especially the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products which has been made effective since January 2018. I had briefly reviewed this document as soon as it was released on 29-Sep-2017. Subsequently, I wrote a more detailed report for DIA’s Global Forum magazine (January 2018 edition) and was also interviewed by Pharmabiz magazine on 21-Jun-2018 on this subject. Oviya MedSafe conducted two instances of training programmes for Pharmacovigilance Officers in Charge (PvOI) candidates of MAHs in January and June, both of which were well received. The implementation of the Guidance Document has resulted in an obvious increase of workload of Indian MAHs (which term includes any organization that holds a valid marketing or import license in India, whether it is an Indian/foreign headquartered company or has generic/innovative products), irrespective of the nature of the organizations.

Oviya MedSafe has a proven track record of more than six years of delivering India-focused pharmacovigilance services with incomparably high quality levels in a very cost-effective manner, thanks to the robust written procedures we have in place for every activity we do. Although our core SOPs (Standard Operating Procedures) were designed having global pharmacovigilance practices in mind, we ensured that we then created specific work instructions and/or guides for supporting Indian MAHs with the local pharmacovigilance requirements laid out by the competent authorities. This has enabled us to support all Indian MAHs with the following activities, in addition to the services we were offering as of October 2016:

# – Preparation of Pharmacovigilance System Master File (PvMF) for India;

# – Training & Certification of PvOI candidates (general and company-specific);

# – Establishment of a Pharmacovigilance Quality Management System (QMS);

# – Consulting for Pharmacovigilance Inspection Readiness in the Indian context; and

# – Authoring Risk Management Plans (RMPs) as and when requested by Indian authorities.

We at Oviya MedSafe are proud of the long-term partnerships our clients, especially those for whom we provide India-specific pharmacovigilance services, have been having with us. We believe this is because of the unparalleled comfort levels they have with us, as they trust us completely. Oviya MedSafe too has gained greatly due to such alliances as they have resulted in further enhancement of our existing flair for teamwork, not only with our client representatives but also with their global pharmacovigilance service providers and other vendors, thereby guaranteeing a seamless coordination that can only be seen in a single team that works towards a common goal.

On another note, I take the pleasure of inviting you to a conference titled ‘Clinical Research in Europe: What you need to know to successfully enter the EU Market?’ meant for pharmaceutical companies that intend to introduce their products in Europe. The conference, which is to be organized by Germany-based Lumis International and co-organized by Oviya MedSafe, shall be held in New Delhi on 15th November 2018 and will have me speaking on the topic ‘Product Safety Monitoring in Europe After Approval‘. Registration is free of cost, mandatory and is limited only to 50 participants. For more information, please download the conference brochure (with agenda) from Oviya MedSafe’s downloads page.

Before signing off, I wish to share with you the regional report titled ‘India Perspective on Patient Engagement in Clinical Trials‘ written by Dr Chirag Trivedi (Director, Clinical Study Unit, Sanofi, India) for the September 2018 edition of DIA’s Global Forum magazine of which I am the honorary Regional Editor for India. I am sure you will enjoy reading this opinion piece as much as I did.

Eager to meet you through our October 2018 edition,

With thanks & regards,
Dr J Vijay Venkatraman

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

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