Offshore Outsourcing in Pharmacovigilance Set to Expand Rapidly

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In this interview Humaira Qureshi, Vice President Pharmacovigilance, Outsourcing, Kinapse, speaks to Pharma IQ about improving drug safety and a move towards pharmacovigilance offshore outsourcing in the biopharmaceutical industry. Qureshi's responsibilites include programme management of key pharmacovigilance outsourcing projects, client interface and providing strategic guidance on pharmacovigilance consulting and outsourcing.

How is the industry seeking to transform data collection to decision support for improved drug safety?

With the new pharmacovigilance legislation fast approaching in July 2012, stakeholders should be prepared for more organised data collection in the periodic reports in particular. Currently in pharmacovigilance the same report may be sent to numerous competent authorities within the EU. From July 2012-
·         All ADRs from companies and from Member States are sent to Eudravigilance only (15 days for serious and 90 days for non serious)
·         Member States are ‘auto-forwarded’ their national data
·         Companies access reports in Eudravigilance

With this change, the EMA and regulatory agencies monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the risk benefit balance whilst the stakeholder too may utilise Eudravigilance to review data collected on competitor products compared to to their own data stored within their drug safety databases.
This means the emphasise will be placed correctly on the review of the outputs of drug safety reporting.

ADR reporting will be simplified(but will introduce patient reporting, reporting of medication)
Literature monitoring will be undertaken by the EMA so that MAHs would still be obliged to carry out literature monitoring for signal detection and ongoing safety review of their products, but they could review articles pertaining to their products via the EMA.

PSUR submission simplified (submitted electronically) and no line listings – as the ADR data will already be in Eudravigilance
Before all of this can happen, there is some work going on
          Format of the ICSR – E2B(R3)
          Drug/Product Dictionary – IDMP,
          Routing of ICSRs via gateway
          Data cleansing project
There is an emerging environment for regulatory and pharmacovigilance offshore outsourcing within the biopharmaceutical industry, why do you think this is?

Today, all life sciences businesses need to evolve to succeed and grow in a challenging external environment. As electronic submissions continue to replace paper, companies can now be more flexible about where they locate the resources delivering business processes. Moreover, with eCTD, E2B and other forms of electronic submission becoming commonplace in the core ICH countries and beyond, leading global regulatory affairs groups can take advantage of these trends to diversify and reduce their cost base through offshoring strategies. While several functions in major global life sciences companies such as IT and data management have a significant track record of offshore resourcing, perceptions of intellectual property risk and regulatory compliance concerns have seen regulatory affairs and pharmacovigilance organisations only just start the process of offshore resourcing of core regulatory affairs processes.
However, these concerns are mitigated by growing confidence in patent protection in markets such as India and China and a relatively positive acceptance of offshore resourcing models by Health Authorities for instance in clinical trials execution and adverse event case processing. In this respect, Kinapse has recently been retained by the European Medicines Agency to undertake a major project in EudraVigilance.

Do you think offshore outsourcing in regulatory affairs and pharmacovigilance will expand rapidly?

Yes for sure. We expect that offshore outsourcing in regulatory affairs and pharmacovigilance will expand rapidly in three complementary approaches:

-In full service submission outsourcing (suitable for variations, renewals, ICSR case processing and quality reviews and PSURs and Annual Reports (DSURs)) all activities across the document lifecycle (from requirements gathering and planning to handling HA questions) are outsourced. This approach is being followed by companies primarily for mature products in international markets.

-In functional submission outsourcing (most suitable NDAs, MAAs and other major submissions) activities which are increasingly outsourced offshore include submissions project management, authoring of CTD modules and publishing.

- Non-submission related offshore outsourcing (covering regulatory intelligence, due diligence, systems support, resource and performance management) includes novel areas for which the capabilities are often not required consistently within the client organisation or are more efficiently shared across organisations and cost advantages achieved through use of lower cost resources.

For anyone interested in attend Pharmacovigilance Asia 2011, what will be your key take home message?

It’s a learning opportunity for everyone. Understanding key changes ready to be implemented in EU, understanding the impact of these changes on stakeholders. Most importantly it’s an opportunity to share ideas with each other and discuss views and opinions related to the ever dynamic pharmacovigilance arena.

Interview conducted by Andrea Charles.