Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned

Clinical Trials, Drug Safety, Life Sciences, Pharmaceutical,
  • July 25, 2017

The Global Market Insights Inc. newswire in Dec 2016 predicted that pharmacovigilance market size is expected to exceed USD 8 billion by 2024, according to their new research report.

 As the demand for new therapies increases, so does the need to comply with regulatory requirements across the pharmaceutical industry, which is on the constant lookout for newer, more efficient ways to tackle the ever increasing load of adverse event data. Sometimes the need is driven by a lack of availability of the necessary parts of the system to implement pharmacovigilance on time by first-time marketing authorization holders. Other times, it may be the need to streamline processes and reduce wastage by larger companies, in order to have a more robust and compliant reporting system. More and more companies are looking at outsourcing as a possible solution to their short or long term needs.

 During this webinar, pharmacovigilance experts from Bioclinica will present case studies of how market authorization holders and CROs are becoming partners of choice in the ever changing world of pharmacovigilance outsourcing by:

    • Streamlining and globalizing processes to increase compliance rates with regulatory agencies
  • Increasing productivity and reducing time to market
  • Focusing on quality of data and employing business excellence strategies in identifying more effective ways of presenting accurate and meaningful data
  • Employing tools that help market authorization holders achieve ease of operation and better transparency

Through presented case studies, market authorization holders will gain important insight into pros and cons of outsourcing pharmacovigilance solutions for their specific clinical trial needs.

Speakers

Sukrit Singh, Associate Director, CRM, Bioclinica, Inc.

Sukrit Singh is Associate Director, Engagement Management, CRM at Bioclinica. Sukrit works within the Safety and regulatory space and is responsible for ensuring customer satisfaction. Sukrit has been with Bioclinica for the past 6 years has managed various projects for Bioclinica from initial set up all the way through completion for its global Pharmacovigilance clients across regions including USA, EU and India. With experience in PV and MICC, Sukrit also works as an SME and has the ability to problem solve issues in real time. Sukrit has hands on knowledge with Lit TRACE and Sig TRACE tools used for effective management of literature search and signaling activities. Sukrit is based out of Boston, MA.

Dr. Ayesha Hussain, Associate Director, CRM, Bioclinica, Inc.

Dr. Ayesha Hussain is Associate Director, Engagement Management, CRM at Bioclinica. She is a medical doctor by education with 12 years of experience in all aspects of Pharmacovigilance/Drug safety including but not limited to ICSRs, aggregate reports, signal and risk management, medical information management, safety database support, MedDRA and WHODrug coding. She has managed various projects for Bioclinica from initial set up all the way through completion for its global Pharmacovigilance clients across regions including USA, EU, India and Japan. Dr. Hussain is based in Chicago, IL.

Who Should Attend?

C-level and senior professionals working within:

  • Clinical Operations
  • Clinical Outsourcing
  • Drug Manufacturing
  • Drug Safety / Pharmacovigilance
  • Project Management
  • Regulatory Affairs

Xtalks Partners

Bioclinica

Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.

Bioclinica’s Safety & Regulatory Solutions is a global, dedicated division within Bioclinica’s eHealth Solutions business segment. The Safety & Regulatory Solutions division offers comprehensive services to support every aspect of your business, and is comprised of over 1,000 healthcare and technology professionals worldwide with extensive domain expertise across all aspects of pharmacovigilance and regulatory compliance. Bioclinica brings clarity to the clinical trial process so sponsors can see key details, uncover hidden insights, and make better decisions. Learn more at bioclinica.com.

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