I am delighted to present to you this October 2016 edition of Oviya MedSafe’s newsletter, by which I intend to provide an overview of Oviya MedSafe’s customizable support services meant to address the local pharmacovigilance requirements of Indian affiliates of global pharmaceutical companies (manufacturers/importers).
The term ‘Local Affiliate’ typically refers to a Strategic Business Unit (SBU) of a foreign parent organization that has the mandate of carrying on the business activities of the enterprise in a particular country or region, in line with the global policies and local laws. Local affiliates may either be locally incorporated subsidiaries of the foreign parent organizations or may also be third parties bound to the enterprise by contractual agreements. In the global pharmaceutical industry, many companies operate in the ‘Local Affiliate’ model. The general functions of local pharma affiliates may vary based on whether the parent company is an established innovator pharma, a multinational generic drugmaker, an emerging biotechnology firm, a vaccine producer, a medical device manufacturer or any other entity. Further, each enterprise may have its own structure and hierarchy for its local affiliates.
The scope of pharmacovigilance activities at a local affiliate level is drastically different from that at a central processing unit which performs routine global pharmacovigilance activities. A local affiliate has the primary responsibility of complying with the pharmacovigilance regulations at the country/region level, while also ascertaining that the activities do not contradict the global pharmacovigilance policies of the organization. While achieving this is a huge challenge by itself, the affiliate has the additional responsibilities of promptly submitting ICSRs/PSURs/RMPs and other pharmacovigilance reports to the competent national/regional authorities, maintaining Safety Data Exchange Agreements (SDEAs) with other applicable stakeholders, providing pharmacovigilance training to business partners & staff, performing local literature monitoring and being in charge of pharmacovigilance audits & inspections of the affiliate. Apart from these activities, pharmacovigilance departments in the affiliates provide support to their Medical Affairs and Clinical Trials colleagues, whenever business needs arise. The affiliate also needs to function as a local point of contact for pharmacovigilance in the concerned country/region, especially for regulatory interactions. In some countries, a person has to be named as Qualified Person for Pharmacovigilance (QPPV) or Local Responsible Person (LRP) for such purposes. The volume and complexity of work at any given local affiliate is largely dependent on the maturity of the respective local regulatory agency.
With the increasing trend of centralized outsourcing of global pharmacovigilance operations to end-to-end service providers, pharmaceutical companies do not find continuous business needs which warrant sizeable pharmacovigilance teams at the affiliate levels. However, this poses a challenge when the affiliate’s workload increases due to unforeseen reasons such as a sudden safety concern or a change in regulation. Since affiliates have their own inherent and regular duties to fulfil with their limited headcount, such spikes in workload can potentially threaten their compliance status. Anticipating such situations, many pharmaceutical companies hire specific third party service providers for local pharmacovigilance support, whenever in need. This partnership differs to a great extent from the centralized outsourcing relationship the company has with a much larger service provider, as focus on and a realistic understanding of the local market scenario are more important determinants in such situations. In fact, a small to mid-sized boutique consultancy with a strong business presence in the concerned country/region may be able to better cater to such specific local requirements than a huge central processing unit.
Oviya MedSafe, despite being a comprehensive global pharmacovigilance consulting and outsourced drug safety services partner for a number of clients worldwide since 2012, has always been at the forefront in supporting Indian pharmaceutical companies and Indian affiliates of global pharmaceutical companies for their local compliance too. Some of Oviya MedSafe’s successful deliveries in this segment include the following activities:
– Corporate pharmacovigilance training;
– Writing PSURs for submission to CDSCO;
– Local literature monitoring;
– ICSR processing & XML-E2B format reporting to PvPI; and
– Analysis of safety data from patient support programmes.
We at Oviya MedSafe, with our rich experience in Indian pharmacovigilance, are empowered to undertake all the pharmacovigilance responsibilities of Indian affiliates of global pharmaceutical companies either in total or in parts, including safety management of company-sponsored clinical trials and postmarketing surveillance studies in the country/region with deployment of a regulatory-compliant drug safety software database where required. We believe that we are highlighting this particular segment of our portfolio of offerings at the right time, as the Indian regulatory system gears up to perform audits on Marketing Authorization Holders (MAH) while urging them to establish well-integrated pharmacovigilance systems in their organizations.
If you wish to know more about these featured services of Oviya MedSafe, please do not hesitate to contact us.
I hope you found this communication to be of interest and thank you for your patient reading.
Looking forward to connecting with you through our November 2016 newsletter edition,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,