DIA 2021 Virtual Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-567-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regulators have a duty to oversee compliance with national and international regulations, which is often allied to supporting and encouraging innovation and ensuring regulatory burden on industry is appropriate. The inspection universe continues to grow, and the complexity of operations has increased with the adoption of new technologies and an increasing number of novel approaches to the development of medicines. As a result new and innovative approaches to inspections have to be developed. Sole reliance on physical inspections is becoming increasingly outdated and is often not the most effective use of resource for the Regulator or Industry. The development of inspection activities which are flexible, risk focused and do not put unnecessary burden on industry is an important consideration. Central to this aim is the development of remote inspection strategies and record sharing approaches that benefit the regulator and Industry alike. This session will explore these new approaches from a regulatory and industry perspective.

Learning Objectives

Explore novel methodologies for performing regulatory inspections that provide benefits to both Regulators and Industry, whilst ensuring the safety and quality of medicines; Assess the advantages and disadvantages of new inspection models from both sides of the fence with a focus on oversight, efficiency, and cost saving; Analyze and trial the use of new and established technologies to aid the conduct of remote inspections.

Chair

Paula Walker, MA

Speaker

Novel and Flexible Approaches to Monitoring Regulatory Compliance Across the GXP Environment: MHRA Perspective
Paula Walker, MA

Panelist
Lesley Graham

Panelist
Hiromichi Isaka, MPharm

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-580-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum, leaders from regulatory authorities will present trends they are seeing in inspections, discuss emerging compliance challenges, and answer questions on expected practices that support success in quality in clinical development.

Learning Objectives

Discuss trends observed in recent inspections and understand specific areas of interest of regulatory authorities; Describe how quality management systems and risk-based approaches need to evolve to address emerging challenges; Recognize regulatory expectations.

Chair

David Fryrear, MS

Speaker

Panelist
David C. Burrow, JD, PharmD

Panelist
Hocine Abid, MD, MBA

Panelist
Paula Walker, MA

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-608-L04-P; CME 1.00; IACET 1.00; RN 1.00

The list of digital solutions for life science companies continues to grow. But what really adds value? This session provides an overview of the digital opportunities across the product lifecycle, and the challenges and opportunities of each.

Learning Objectives

Define existing and emerging solutions for digital integrations across the product lifecycle; Evaluate challenges and opportunities of integrating and implementing these digital solutions.

Chair

Jessica Federer, MPH

Speaker

Panelist
Cindy Hoots

Panelist
Bruno Villetelle, MS, MSc

Panelist
Karenann Terrell

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-652-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regulator panel perspective on maintaining GCP compliance during a pandemic, including challenges in remote working, good risk assessments to guide decisions, innovation to meet compliance while ensuring regulatory flexibilities are met.

Learning Objectives

Describe global regulator views on issues affecting GCP compliance during a pandemic and future proofing beyond; Describe regulatory challenges such as working with the need for regulatory flexibilities and challenges in innovating to maintain compliance using remote ways of working; Discuss using good risk assessments to guide decisions.

Chair

Paula Walker, MA

Speaker

MHRA Update
Gail Francis

FDA Update
Barbara D Wright

Danish Medicines Agency Update
Lisbeth Bregnhoj, PhD, MPharm

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-662-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide information to discuss regulatory and sponsor oversight and the need to increase the communication risks to stakeholders in real-time for critical study-related activities, and how sponsors need a system that will predict and manage risk using modern digital technology platforms.

Learning Objectives

Describe compliance risk prediction possibilities and how a digital technology platform, risk predictor, helps to capture, identify, mitigate, trend risk, and prioritize actions that are important to the pharma and medical device industry; Discuss how to integrate data from different data sources/platforms and shown tools.

Chair

Kamal Biswas

Speaker

Panelist
Sherri Ann Hubby

Panelist
Andrew Fisher, MS

FDA Update
Cheryl Grandinetti, PharmD

Panelist
Jane von Kirchbach, MBA