Conference Day One

8:30 am - 9:00 am Registration and Coffee

9:00 am - 9:10 am Chairwoman's Opening Remarks

9:10 am - 9:40 am Speed Networking

A highlight of Pharma IQ events! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers. There is a prize in it for the winner, so, get networking!
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge

9:40 am - 10:20 am TMF Quality: A Post-Inspection Story

Gergana Koutsarova - Global TMF Process Owner, AstraZeneca
• Look at re-evaluating TMF critical to quality factors
• Discuss Oversight Expansion or Withdrawal and when either is necessary 
• Review stepping onto a new level of TMF maturity 

img

Gergana Koutsarova

Global TMF Process Owner
AstraZeneca

10:20 am - 10:50 am Networking Coffee Break

10:50 am - 11:30 am Case Study: Managing Sponsor Oversight in a Short Inspection Notice Period

Padma Iyer - Senior Manager, Clinical Operations, Eisai
• Understand the importance of continuously assessing TMF metrics with your CRO
• Learn how to monitor GAP Analysis and stick to set-timelines both internally and with your CRO
• Re-inforce the importance of monitoring critical documentation in your TMF

img

Padma Iyer

Senior Manager, Clinical Operations
Eisai

11:30 am - 12:10 pm Case Study: Practical Experience with Regular Activities to Ensure Inspection Readiness

Elke Ufer - Quality Manager Compliance, Grünenthal
• What can we do as individuals and company on a daily basis to be inspection ready?
• Review a case report of the “Document Day”: Mock-Inspection in a different way
• Understand the concept of compliance assessments by quality staff: Alternative to internal audits

img

Elke Ufer

Quality Manager Compliance
Grünenthal

12:10 pm - 1:10 pm Networking Lunch

1:10 pm - 1:50 pm Case Study: TMF Audit Plan Based on Study Risks and Milestones

Mary MacDonald - Director, GCP Quality Assurance, Radius Health
• Develop a program-wide TMF audit plan based on study risks and milestones
• Develop a risk-based study-level TMF audit plan focused on document sampling strategies
• Engage stakeholders in responding to audit observations and mitigating GCP noncompliance
• Leverage initial findings to drive proactive compliance, particularly at the process and structure level

img

Mary MacDonald

Director, GCP Quality Assurance
Radius Health

1:50 pm - 2:30 pm GCP for Medical Devices – Sponsor’s Early Learnings with ISO 14155:2020

Milos Stojkovic - Senior Safety Specialist, Global Medical Affairs, Smith & Nephew
• Discuss key updates brought forward with 2020 revision of ISO 14155 GCP for Medical Devices
• Look at setting priorities: Crucial, Should-be-done and Let’s-see 
• Learn to identify gaps and gain managerial support 
• Review MDR integration and specifically where to leverage GCP for MDR compliance and clinical data generation 

img

Milos Stojkovic

Senior Safety Specialist, Global Medical Affairs
Smith & Nephew

2:30 pm - 3:00 pm Networking Coffee Break

It is no secret that the best strategies are formed through expert collaboration! During this activity, break off into small groups and collaborate with your peers. Choose one topic below and after 30 minutes; rotate around to another topic area for discussion.

1.Preparation for an MHRA Inspection
             Rebecca Halbur, Senior Manager Trial Master File, Biogen

2.Transitioning to an eTMF
               Sarah Neglo, Clinical Research Associate, Chiesi

3.Patient Engagement in Clinical Development  
               Nancy Meyerson-Hess, Chief Compliance and Regulatory Officer, eMQT

4.TMF Audit Plan 
               Mary MacDonald, Director, GCP Quality Assurance, Radius Health

img

Rebecca Halbur

Senior TMF Manager
Biogen

img

Sarah Neglo

Clinical Research Associate
Chiesi

img

Nancy Meyerson-Hess

Chief Compliance and Regulatory Officer
eMQT

img

Mary MacDonald

Director, GCP Quality Assurance
Radius Health

• What measures can you take to avoid a back log with your filing?
• Do you perform spot-checks and how many times do you have missing documentation?
• Determine strategies you can put in place to ensure your TMF system is complete

img

Karin Liljeberg

Director Clinical Operations
Ascelia Pharma

img

Rebecca Halbur

Senior TMF Manager
Biogen

img

Brenda Brown

Director, TMF Operations Lead
Pfizer

img

Monica Alaimo

Director, TMF Operations
Syneos Health

4:40 pm - 4:50 pm Chairperson's Closing Remarks

4:50 pm - 5:50 pm End of Day One & Networking Drinks Reception