Live Online Conference: GMP & GDP Forum 2021 - Registration for 1, 2 or all 3 Days
Im Auftrag der ECA Academy

Live Online Conference: GMP & GDP Forum 2021 - Registration for 1, 2 or all 3 Days Im Auftrag der ECA Academy

Seminar Nr. 18476


Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Ib Alstrup, GxP IT Medicines Inspector with the Danish Medicines Agency, DMA, Denmark
Dr Christopher Burgess, Qualified Person, Chaiman ECA Quality Control Group, UK
Cheryl Chia, Lotus Phoenix Consulting, Netherlands
Prabjeet Dulai, GDP & Quality Matters, UK
Dr Rainer Gnibl, GMP Inspector, District Government of Upper Bavaria, Germany
Jochen Heinzel, F. Hoffmann-La Roche, Switzerland
Dr Afshin Hosseiny, Qualifed Person, Chairman ECA Foundation and European GDP Association, UK
Saddam Huq, GlaxoSmithKline, U.K.
Dr Ulrich Kissel, Chairman, European QP Association, Germany
Gert Moelgaard, Chairman ECA Validation Group, Denmark
Helga Peters, Switzerland
Axel Radke, Trust Expertenservice, Germany
Jonathan Riley, Astellas Pharma Europe Ltd
Dr Bernd Renger, Qualifed Person, Immediate Past Chairman European QP Association, Germany
Maria Sekamwa, Surgipharm, Uganda
Dr Franz Schönfeld, District Government of Upper Franconia, Germany
Dr Wolfgang Schumacher, Chairman ECA Data Integrity & IT Compliance Group, Switzerland
Lance Smallshaw, UCB Biopharma sprl, Chairman ECA Cannabis Group, Belgium
Dr Ingrid Walther, Pharma Consulting Walther, Former Head of the Business Unit iv Drugs, Fresenius


I would like to invite you to the European GMP & GDP Forum from 22 – 24 June 2021.
Our ECA members are familiar with biennial conferences on GMP and GDP we have been running for several years. However, we have now developed this unique Forum by combining the European GMP Conference and the European GDP Forum. I believe with this new event by combining both GMP and GDP subjects, we have created a new opportunity for you to meet delegates and expert speakers from across the industry, and exchange views and learn about the whole Pharma supply chain challenges.
We have dedicated day 1 to GMP, day 2 will be a combination of both GMP, and GDP and the nal day will be focussed on GDP topics only. - is will allow you as a participant to take advantage of the event based on your personal needs and interest in the speci c subject areas, you can now choose to attend the forum just for one of the three days, two days or all three days. We intend to host the Forum every two years which I am sure will become a major European event for GMP and GDP professionals. For our rst Forum in June 2021 we have invited speakers from Regulatory Authorities and Pharmaceutical Industry to share and discuss with you the latest GMP & GDP developments.
I look forward to meeting you either live online or in person in Heidelberg, Germany – one of the most beautiful cities in Europe!


The conference is of particular interest for GMP experts of pharmaceutical companies (e.g. QA, QC, production, regulatory a airs), of GMP inspectorates and Regulatory Authorities. It is also of interest for all personnel involved in GDP – pharmaceutical storage, transportation, cold chain and Distribution activities and the control of these activities.


Programme 22 June 2021 - GMP Part
Moderated by: Lance Smallshaw
Current GMP Initiatives Worldwide
This session will discuss the latest changes and current initiatives in GMP and GDP regulations.
GMP Update 2021 and Outlook 2022 – Current Trends and Developments in Europe and the US
Dr Bernd Renger, QP and immediate past chair of the EQPA
  • Major GMP developments and their impact for pharmaceutical industry
  • GMP Revisions – Annex 1 & 21
  • GMP for Marketing Authorisation Holders
  • The new EU GMP Annex 21 on Importation and its implication
  • Analytical Procedure Development and Validation (ICH Q14/Q2)
  • Other GMP Developments from EMA, FDA and others
  • Brexit and its consequences for the European QPs
ICH Q 12: Views and Expectations of a GMP-Inspector
Dr Franz Schönfeld, GMP Inspector
  • Quality Risk Management
  • Life Cycle Approach
  • Views and Expectations
How to Implement ICH Q 12 into Daily Practice of Manufacturers – What QA (and QPs) needs to know?
Dr. Ulrich Kissel, Chairman European QP Association
  •  What does QA (and QPs) need to consider?
  • Some Quality systems become key
  • Efficiency potential for Quality systems of manufacturing organizations
  • ICH Q12 and key performance indicators
  • Plan precisely, assess risks proactively, share transparently
Industry Meets Inspectors

GMP Inspections from Russian Authority in Europe
To be named
Global Inspection Management: Cultural Differences to consider in hosting Competent Authorities from e.g. Arabic Countries, China, Korea, Taiwan, Mexico, Russia
Helga Peters, Basel, Switzerland
  • General Organisation
  • Roles and Responsibilities
  • Preparation
  • Cultural Aspects
Annex 1 Revision: Comments from the Industry
Dr Ingrid Walther, Head of ECA´s adhoc Task Force for comments to the Annex 1 revision
  • New requirements?
  • New requirements!
  • The role and improtance of Quality Risk Management
  • Contamintation Control Strategy
Inspection – readiness for new Annex 1: Comments from the Inspector
Dr Rainer Gnibl, GMP Inspector
  • What is essential?
  • What do I need to change or improve?
  • Is it really such serious?
Programme 23 June 2021 - GMP & GDP Part
Moderated by: Dr Urich Kissel
Brexit: Consequences for GMP and GDP Environment
Dr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association
  • What is the impact of Brexit on Pharma Regulations?
  • New GMP and GDP expectations from UK
  • How Pharma Industry in EU should manage the UK Business
  • What impact all this has on the patients?
EU GMP Annex 21: Import of Medicinal Products
Dr Ulrich Kissel, Chairman European QP Association
  • The meaning of importation within scope of Annex 21
  • What is new in Annex 21 (dra  )?
  • What do we miss in Annex 21 (dra  )?
  • Conclusions and comments on the document
Parallel Sessions & Workshops with Inspectors
Option 1 (Validation Group): Quali- cation & Validation: Supplier integration – how does this fit with GMP?
Option 2 (Quality Control Group): QC: How sure are you that your Laboratory Instrument/System is fit for its intended Purpose?
Option 3 ( Data Integrity & IT Compliance Group): Data Integrity: Data Integrity in the GMP area
Option 4 (GDP Group): How to Identify and Manage Falsified Medicines in the Supply Chain
Option 5 (GDP Group): Risk Management in GDP Warehouse
Inspections/Audits in Covid-19 Times
The corona pandemic causes unusual supplier qualication activities. Meetings face-to-face are reduced or not possible at all. - is concerns supplier audits but also regulatory inspections. To full GMP-requirements and to prevent travelling and meeting people personally is a balancing act. How to react?

Distant Assessments – GMP-inspector´s view
Dr Rainer Gnibl, GMP Inspector
  • Regulatory Basis
  • Requirements from guidelines
  • Examples from inspections
  • Reliability in “real life”
Supplier Management during Covid-19 Pandemic
To be named
Programme 24 June 2021 - GDP Part
Moderated by: Dr Afshin Hosseiny
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. - is is where Good Distribution Practice (GDP) comes into play. On day 3, challenges and possible solutions will be discussed and examples will demonstrate how the requirements can be put into practice.

GDP Update & Outlook
Dr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association
  • Major GDP developments
Case Studies: When Things go Wrong – What can Happen in the Real World?
Axel Radke, Trust Expertenservice
  • First plan, then start
  • Hand in hand for safe transport
  • Basis of all considerations “Worst Case Scenario”
Case Study: The Switch from Air-freight to Sea-Freight
Saddam Huq, GlaxoSmithKline
  • Challenges and Benefits
  • Examples
GDP Challenges in Africa
Maria Sekamwa, Surgipharm
  • Background
  • Evolution of GDP over the years
  • Problems involved
  • Steps taken to improve
Case Study: The Roche Quality Governance Model for Distribution to Direct Markets
Jochen Heinzel, F. Hoffmann-La Roche
  • Selection, implementation, operation and decommissioning of partners
  • Key Performance Indicators (KPIs)
  • Compliance score card
Master Data
Cheryl Chia, Lotus Phoenix Consulting
  • EU requirements
  • Master Data framework for Medicines
  • Impact to the Pharmaceutical Supply Chain
  • QA/QP/RP oversight of the supply chain
GDP Responsibilities for Financial Trading Organisation
Prabjeet Dulai, GDP & Quality Matters &
Jonathan Riley, Astellas Pharma Europe
  • Involvement of Marketing Authorisation Holders in the Distribution network
  • The role of the Responsible Person when product handling is not involved
  • Control of outsourced activities in integrated supply chains
  • Processes used in nancial distribution, and validation of computerised systems


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