Qualified Person Forum

IMP Conference Day

Specific Requirements for IMP QPs
9.00-18.00 h

Click on the image to open the programme as PDF

Facilitated by:
Susanne Ding | Rebecca Haywood | Katrien Himpens | Patryk Jegorow | Markus Roemer (other speakers invited)

• Legislation impacting IMP QPs (incl. Annex 11)
• Data Quality and Data Management
• Inspector’s view
• Product Specification File
• ATIMP release and valuable learnings
• Interactive case studies
• Early Access Treatments
• Medical Devices
• Q&A sessions

1/2 Day Pre-Conference Sessions

What the QP needs to know about Data Quality and Data Management
13.30-18.00 h

Facilitated by:
Cheryl Chia | Rainer Gnibl | Markus Roemer

• Overview on current EU-requirements on Data Governance and Data Integrity
• Data Quality as a decision basis for batch confirmation and certification
• The wild mix on a QP’s desk: Oversight of paper-based, hybrid and digtal data
• Digital systems, MES, eBR, data warehouse – where the QP must be cautious
  
  

New QPs meet experienced QPs
13.30-18.00 h

Facilitated by:
Björn Cohrs | Sue Mann | Ewa Rybak

A tailor-made session for new and aspiring QPs with round table discussions and lots of interaction. It is a safe space where issues, questions and any worries relating to the role of a QP can be discussed with experienced QPs and a GMP Inspector.