Free Live Roundtable Recording On the Back of the Curve:

The State of Pharmacovigilance in 2020

Covid-19 will have far reaching effects on how pharmacovigilance and drug safety departments operate. If you’ve dealt with pharmacovigilance through COVID-19 with a short-term, survival mindset than you are missing a huge opportunity to drive positive change for your organization.

Moderated by Advera Health, this virtual roundtable discussion with industry experts discussed the current state of pharmacovigilance as we emerge past the first wave of the Covid-19 crisis and where there is opportunity to adapt procedures, policies, vendors, and software

The discussion focused on:

  1. From the front lines: What does the reopening of medicine look like and the implications for safety.
  2. How are regulatory authorities now looking at pharmacovigilance long term? Has anything changed?
  3. How will the future of PV operations be impacted?
  4. Long term effects on signal detection and management
  5. Impact on PV technology decisions
Industry Expert Panelists:
Catherine Baldridge, Essential Pharmacovigilance

CATHERINE BALDRIDGE

Essential Pharmacovigilance

Catherine is the Principal Consultant and Owner of Essential Pharmacovigilance, a company dedicated to providing expert consultancy, training, and services for companies who need assistance with their Clinical Safety & Pharmacovigilance activities. She is also a Professor of Pharmacovigilance at Temple University, a current member of the Community Leadership Council and the former chair of DIA Clinical Safety and Pharmacovigilance Community.

DR. MURALI DORAISWAMY

Duke University School of Medicine

Dr. Doraiswamy is a physician and highly cited clinical trials and pharmacovigilance researcher at Duke University School of Medicine where he serves as Professor of Psychiatry and Medicine.  He has been a principal investigator on many landmark outcomes studies of drugs, devices and diagnostics, and is the co-author of over 300 publications.  Murali has served as an advisor to leading government agencies (such as the NIH, FDA and WHO), pharmaceutical companies and patient advocacy groups.  He is a member of the World Economic Forum’s Global Future Councils and a scientific advisor to Advera Health.

Dr. Murali Doraiswamy, Duke University School of Medicine
Dr. Michael Forstner, PRA Health Sciences

DR. MICHAEL FORSTNER

PRA Health Sciences

Dr.  Forstner is a Senior Director in the Patient Safety department at PRA Health Sciences. He has over 20 years industry experience in various roles in R&D and drug safety in different pharmaceutical companies, at a CRO, and as an independent consultant, and has contributed to several successful marketing authorizations of innovative medicines by developing workable, efficient risk management measures. Michael has been the acting chair of the PV working group of Medicines for Europe since 2018, representing the organization at EMA working group and stakeholder meetings; in this function he is also a delegate to the ICH for the International Generics and Biosimilars Association. Michael is also a core member of the ISPE Task Force on Real World Evidence.

ALEXANDER GAFFNEY

POLITICO - AgencyIQ

Alec is the Senior Director of Research at POLITICO’s AgencyIQ, where he leads the team’s research and analysis of life sciences regulatory issues affecting the Food and Drug Administration. Alexander previously worked at the consulting company PwC where he led analysis of life sciences regulatory issues for the firm’s prestigious Health Research Institute. Before joining PwC, he was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also was Managing Editor of the company’s flagship publication, Regulatory Focus. Alexander is regularly asked to speak to executive audiences about regulatory policy developments, and his work has been cited in Congress and by major media outlets and medical journals. He has maintained his Regulatory Affairs Certification (RAC) in US regulation since 2013.

Alexander (Alec) Gaffney, POLITICO - AgencyIQ
Anjani Jha, Nextrove, LLC

ANJANI JHA

Nextrove, LLC

Anjani is the founder and CEO of Nextrove, a global professional services firm with the mission to deliver preeminent and innovative solutions that enables the global Health Science industry to improve public and patient safety.  Anjani responsible for the overall direction and management of Nextrove and has guided the company’s growth, mission, and vision since its inception. Anjani brings over 16 years of experience architecting and implementing solutions in the life science industry. Prior to founding Nextrove, Anjani held leadership positions in product solutions, delivery and business development at various life sciences technology companies including IQVIA, HighPoint Solutions, November Research Group, Foresight Group, Oracle HSGBU, Relsys International and Computer Sciences Corporation (CSC).