This quarterly eNewsletter will keep you informed of news and trends as it relates to pharmacovigilance and patient safety within clinical development. We will also share insights and updates from PRA's pharmacovigilance and patient safety team.

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Edition Highlights:

Literature Surveillance in Pharmacovigilance

Distiller SR Logo

During clinical development, it is mandated that drug developers perform literature surveillance in accordance with and in support of other surveillance activities, such as ongoing safety evaluation or annual safety reporting (i.e. Development Safety Update Reports, or DSURs). This obligation intensifies when the developer submits a New Drug Application (NDA) or Marketing Authorization Application (MAA) and receives authorization to market its product. It then becomes a requirement to perform a systematic literature review no less than once a week. It is also expected that New Drug Applicants and Marketing Authorization Holders (MAHs) have procedures for monitoring local publications in countries where the product has been authorized for marketing.

Given the amount of available literature and the number of potential sources (i.e., Embase, Medline, Reactions Weekly, Biosis), it is optimistic to expect to find every piece of literature that may be published. Conducting a literature search requires a realistic, pragmatic, and objective approach, along with targeted search strategies. These planning elements ensure that the recall representing the number of results considered relevant is as precise as possible. Despite the best efforts and most sophisticated of strategies, the amount of literature recalled can still be overwhelming, particularly for companies with hundreds of products in development and/or on the market. As with many things, technology and automation can help.

PRA uses DistillerSR from Evidence Partners as a Literature Surveillance platform. Robust platforms can reduce effort and improve efficiency for literature search and review. Technology facilitates standardized, automated workflows that maximize literature operations and provides a single platform/repository for storing surveillance data. When searching multiple data sources, technology also performs de-duplication (i.e., by flagging duplicate results). It highlights keywords to expedite literature reviews and shorten the time for locating relevant information. It is well documented that the deployment of such literature platforms can reduce review times from 20-40%.

Distiller SR Process

Implementation of such robust platforms streamlines oversight and coordination of literature surveillance activities and ensures inspection readiness. Such systems also enable ongoing monitoring of the performance of the process and search strategy by providing access to on-demand reports.

At PRA, Literature Surveillance is overseen by the Safety Scientists within the Patient Safety Team and executed by the Drug Safety Associates within our various Drug Safety Centers.

Luck runs out, but safety is good for life.

Anonymous

PVS Spotlight | Andrew Purchase

Andrew Purchase
Director, Patient Safety Operations, PVS

What is your role at PRA?

I provide guidance and consultancy as an SME for Adjudication, Literature and the Pharmacovigilance System Master File (PSMF). I participate in PRA initiatives for implementation and integration of enhanced PV processes and tools. I am the business system owner for PRA Adjudication and Literature Tools, and I manage and oversee a global team of (currently) 9 Safety Scientists in Patient Safety.

What inspired you to join CRO business and what convinced you to stay with PRA?

I originally “fell” into my role at PRA in 2006. Back then, I hadn’t heard anything about PRA and I initially joined as a Data Manager. At that time the Swansea office was a Data Management Hub. A few years later, I moved into PVS.

I have thoroughly enjoyed my time at PRA, and I have never looked back since joining PVS. The department has allowed me to grow exponentially and presented me with endless opportunities. My experience and ideas are valued, and I have been allowed to contribute to the continued growth of our Patient Safety team.

The variety of my role within PVS keeps me motivated and inspires me to continue working at PRA. We have strong leadership and an excellent team spirit, which makes every day enjoyable. I am proud to be part of this innovative company.

What are your hobbies?

I enjoy playing golf and exercising at the gym. I have a passion for travelling—I am always looking for new places to visit.

Drug Safety Center (DSC): Singapore

The Singapore Drug Safety Center (SIN DSC) was established in 2013 as one of the pioneer departments of PRA Singapore to provide pharmacovigilance and patient safety services in the Asia Pacific (APAC) region. We started off with a humble team of 3 staff members, as we were the first DSC in the APAC region.

Over the years, the SIN DSC has become the largest department in the PRA office in Singapore, with a total of 17 staff members currently. Located in a multicultural metropolitan city, many of the Singapore team members speak various languages and dialects. Most team members are bilingual in both English and Chinese, and qualified for in-house translation and making submissions in local languages.

Singapore with caption for external

The PRA Singapore office is in Biopolis, where many biotechnology and pharmaceutical R&D centers are located in Singapore. Our team is vibrant, energetic and committed to PRA’s mission and vision. We are dedicated in quality delivery and having fun after office hours.

Singapore events

In 2019, PRA celebrated our 15th year anniversary in Singapore. We hope to collaborate and work closer with various departments and provide a wide range of high-quality PVS services. Together, we can finally achieve the common goal of protecting patient safety. Here’s to a never-ending 15 years ahead! 😊

PVS Spotlight | Jing Yang

Jing Yang
Associate Director Drug Safety Center APAC

What is your role at PRA?

I am responsible for managing and overseeing the Drug Safety team in Singapore and Seoul, South Korea including the Drug Safety Associates and Safety Assistants. I also have various regional experience in safety reporting procedures in China, Taiwan, South Korea and Singapore.

What inspired you to join the CRO business and what’s convinced you to stay with PRA?

I joined the CRO business more than 14 years ago as a Drug Safety Associate (DSA). After a friend working in the Ethic Committee introduced the CRO industry and Pharmacovigilance to me, I developed the interest to find out more about CRO business and how it contributes to public health. I believed that the CRO business model would bring competitiveness, flexibility, and the best practice to drug development, which would accelerate new drug development process and ultimately benefiting patients. I have been working on full case processing, projects involving Clinical Event Validation and Adjudication, and as safety lead of global clinical trial programs. My current role focuses on regional growth and direct reports’ career development in PVS. I've stayed with PRA because I find it stimulating to grow business offering here as a holistic team. There is always something new to learn.

What are your hobbies?

My hobbies are reading books, going for runs regularly, meeting up with my friends for Go matches, and spending time with my son.

ORBIT™ by Feith Systems

Orbit 1

Orbit™ (by Feith Systems) is a validated single sign-on web-based application used by PRA to manage and track our global pharmacovigilance processes. These processes include Signal Management, Risk Management and Risk Minimization, and Aggregate Safety Reporting.

With Orbit, users can efficiently track information, manage tasks, review data, set deadlines, and generate reports.

Key Features of the Tool

  • Plan Creation and Review Workflow: Allows creation of plans, with internal and external review
  • End to End Auditability: Provides full audit trail for all changes made and revisions with dashboard to report on status. This level of tracking and documentation in Orbit™ allows PRA clients to be audit and inspection ready at all times.
  • Structured Plan Implementation: Captures version plan details, tracks tasks, measures effectiveness, and monitors global activities.

Risk Management Activities

Orbit 2

Orbit™ captures version details of risk management plans (RMPs) and risk evaluation and mitigation strategy (REMS), tracks post-marketing commitments, activities and milestones, all while monitoring our global process results. It reduces data entry time by distributing commitments, deadlines and documentation from Core RMPs and local RMPs throughout all global markets.

Orbit™ tracks Risk Minimization Measures (RMM) development and implementation globally, tracks local Health Authority feedback, and provides global risk management oversight using dashboard functions.

Orbit 3

Signal Management

Orbit™ provides a comprehensive solution for signal management from signal detection strategy through signal evaluation, verification and management. The tool allows creation of Safety Surveillance plan and signal detection report. Safety Signal Tracker provides a system to track the signal management activities from identification through resolution and closure.

Orbit 4

Aggregate Safety Reporting

Orbit™ allows creation of Aggregate safety report plans and facilitates seamless tracking to scheduling reports, assigning tasks, and authoring documents using PRA or Client templates. With the Activity Milestones, Safety Scientists track commitments. Orbit dashboards bring KPIs such as Upcoming Tasks and Past Due tasks. It allows us to keep track of internal deadlines, Client review timelines and regulatory timelines. Workflows notify users, update statuses, and schedule recurring events to help meet global and local commitments. The tool tracks the completion of all of our reports: PADER, PSUR/PBRER, DSUR, etc..

For any Orbit related questions, please contact the Orbit Global Administrators: SMA - PVS - Orbit Administrators SMAPVSOrbitAdministrators@prahs.com

PVS Spotlight | Joash Krishna

Joash Krishna
Associate Director of Patient Safety

What is your role at PRA?

I’m an Associate Director of Patient Safety in Pharmacovigilance & Patient Safety (PVS). In my role, I support PRA’s specialized PV Services, which include signal detection, safety surveillance, aggregate safety reporting, and literature search and review. I’m also the business owner for the Orbit System and a member of the Spotfire Development Team. Orbit and Spotfire are tools that PRA utilizes to add efficiency to our Patient Safety services.

What inspired you to join the CRO business and what’s convinced you to stay with PRA?

I joined PRA in 2012 and prior to this I was working within a pharmaceutical company that was acquired. PRA was our vendor at that time, and after hearing about our acquisition, PRA reached out to me to see if I might consider joining the company, which I did.

Working within PRA has allowed me to work in a diverse area of safety services that is both an interesting and exciting field of PV. The experience in biosimilars development program allowed us to develop some of our processes such as Signal Detection, Label Surveillance, Literature Search and Review. I also had the opportunity to present at the World Drug Safety Congress on “Evolving Signal Management Approaches in Biosimilars Development to Support Demonstrating Biosimilarity Safety-wise”. PRA also provides me with the opportunity to work with other clients within diverse areas supporting other PV services. It’s different than working directly in Pharma, where you’re specialized in one area typically. The CRO environment is more diverse. It gives me broader insight into what is happening in the industry as a whole, looking at industry trends and identifying what type of service we can develop to support the industry. There is never a dull moment and I enjoy every day, even with challenges. It is great knowing that we are helping to develop products that save lives and support patients. I enjoy the development of a new product.

What are your hobbies?

I enjoy outdoor photography—taking photos of landscapes is refreshing. I love sports and started cross-fit training two years ago. I also enjoy fishing and playing music. I am the Lead Pastor of a small church. I enjoy music, and prior to lockdown, participated in our church band, playing bass guitar and piano. I enjoy working within my community.

Interested in learning more about any of the information mentioned here, have a personal interest in pharmacovigilance, or would like more information?

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