Webinar Ask The Expert

QA experts talk auditing and inspections.

December 7th.

We’re holding a webinar on pharmacovigilance auditing and inspections on December 7th with an international expert panel, and it’s a webinar YOU CAN’T MISS!

Who is on the panel?

We have three renowned auditors who between them have over 60 years of experience within pharmacovigilance.

Hosting the session will be GVP and GCP auditor Helen Lowe from Arriello, and with her will be two leading international auditors, Nazrul Khan and Michael Ramcharan, who both work on behalf of Arriello as part of our global team.

The webinar will take place at:

10.00–11.00 US ET.
15.00–16.00 UK GMT.
16.00–17.00 EU CET.

Register for this free webinar HERE.

Helen Lowe

Hosting our auditing panel is Arriello’s Auditing and Quality Assurance Director. She has over 20 years’ experience within Pharmaceutical Research & Development (R&D), Quality Assurance (QA), Pharmacovigilance (PV) and clinical site auditing, Quality Management Systems (QMS), clinical drug development, post marketing drug safety / PV, and regulatory compliance. 

Helen has a proven track record of participating in and managing/hosting numerous health authority inspections, including with the FDA, BfArM, MHRA, AEMPS.

Helen Lowe Official

Nazrul Khan

With over 20 years of GVP/GCP experience in pharmaceutical and biotechnology companies, Nazrul (Naz) Khan is another one of Arriello’s experienced consultants, supporting us with client projects. 

Having worked and been trained by the MHRA, Naz has an insightful view on the world of auditing from many perspectives. 

Renowned for his global PV auditing experience, we look forward to having Naz on our expert panel of auditors. 

Nazrul Khan

Michael Ramcharan

A renowned PV consultant, Michael Ramcharan has over 25 years of experience within International pharmaceutical and biotechnology companies and Contract Research Organisations (‘CROs’). 

He has a broad range of GxP knowledge and expertise including Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) and supports Arriello’s PV/Clinical Auditing and QA services across auditing, mentoring, training and more.

We are proud to have Michael as part of our expert panel of auditors. He supports Arriello’s PV/Clinical Auditing and QA services. 

MichaelRamcharan

What will we cover?

Following on from our survey where we asked what you’d like our panel to cover, we now have the four key topics we know you’re going to be interested in:

  • Expectations regarding vendor management systems.
  • Auditing automation within Pharmacovigilance.
  • How to best align the CCDS with the SmPC?
  • Non-EU Local Qualified Person v Local EU QPPV v EU QPPV.

Why you need to join us.

All Pharmacovigilance and PV Quality professionals will learn something new and hear some very thought provoking insights from our experts who are covering some of the most relevant topics in the industry right now.

Our panelists are raring to go and super excited about discussing and sharing their knowledge from around the world on the topics covered, so join us on December 7th. The webinar will be recorded.

Register for this free webinar HERE.