European QP Association announces Changes in its Advisory Board

The European QP Association (EQPA), representing close to 2.500 Qualified Persons (QPs) and professionals in similar functions from across Europe and beyond, has announced several changes in its Advisory Board.

A member of the Board since its foundation in 2006, Dr Christopher Burgess stepped down end of 2015. “With more than 30 years of experience in the pharmaceutical industry, mostly in quality assurance and analytical R&D, Chris was one of the driving forces for activities of the European QP Association from the start”, said Richard M. Bonner, Chairman of the EQPA’s Advisory Board. “We’d like to thank Chris for his commitment throughout the last ten years.”

Two further changes concern the authority side: Edit Szőcs who had joined the Board in 2013 as a representative of the Hungarian National Institute of Pharmacy and Nutrition (NIPN) left the agency end of 2015 and thus also resigned from her appointment in the EQPA. As an Inspector, Edit was active in several organisations and working groups (PIC/S, WHO, GMDP IWG) and brought in her expertise from an authority’s perspective. Moreover, Tor Gråberg, Chief Pharmaceutical Inspector and Head of Drug Inspectorate at the Swedish Medical Products Agency (MPA), has been member of the Advisory Board since 2014. Tor also left the agency end of 2015 and is now with AstraZeneca. He will remain on the Board, though. “We appreciate Edit’s support in gaining a better understanding of the regulatory impact of the EU QP regulation”, Bonner commented. “And we are glad Tor will remain and further help to advance the organisation.”

Replacing Edit Szőcs on the authority side is Mag. Pharm. Andreas Kraßnigg from the AGES, the Austrian Agency for Health and Food Safety. He has been the agency’s Head of Pharmaceutical Inspections since 2006 and is responsible for Manufacturer's and Wholesaler's Authorisations and related inspections and certificates. In his position he is also Austria's delegate to the Inspector's Working Group at the European Medicines Agency and Austria's Committee Member of Officials at the Pharmaceutical Inspections Cooperation Scheme, where he is currently also Chair of the Subcommittee on Expert Circles. “I would like to thank the Board for their trust and am very happy to join”, Kraßnigg pointed out in response to his nomination. “We are very pleased Andreas accepted our invitation to join the Advisory Board”, Bonner welcomed the new Board Member.

The Investigational Medicinal Products (IMPs) Working Group has been part of the Association almost from the start, and its pre-conference IMP workshops have been a well-known part since the second annual QP Forum in 2007. Now the QP Association also announced a change in its Working Group’s leadership team. Succeeding Geneviève Meeus from Johnson & Johnson is Brenda Van Assche. Brenda started at Janssen, Pharmaceutical Companies of Johnson & Johnson, about 15 years ago in CMC Regulatory Affairs. After taking up several roles within Quality for about 10 years, mainly in the commercial QP area for different formulation types, she stepped into a Global Quality Role, where she got product responsibility from First in Human trials till Commercial launch. Following she moved on to Marketing and then Sales in the Infectious Disease & Vaccines Therapeutic Area and is now the IMP QP for Janssen. “I feel very privileged to become part of this team and I am looking forward to continue the good work this team is doing”, Brenda said.

The European QP Association is an interest group of the ECA Foundation (please see www.eca-foundation.org for more detailed information). It was founded in July 2006 with the goal to provide QPs in Europe with a platform allowing them to exchange experience, discuss the latest regulatory requirements, to identify and address difficulties and challenges and to support a harmonised European approach. Today, the Association counts close to 2.500 members from across Europe and beyond (from almost 40 countries).

The Association is led by Richard M. Bonner as Chairman of the Advisory Board and three colleagues from the industry side and two authority representatives: Dr Ulrich Kissel (Germany), Tor Gråberg (Sweden) and Dr Susanne Ding (Germany), who is also heading the Association’s IMP Working Group. The authority side is represented by Dr Rainer Gnibl from the District Government of Upper Franconia, Germany and Mag. pharm. Andreas Kraßnigg from Austria’s AGES.

To accomplish its goals the Association developed a number of activities: the online discussion forum for members is used to exchange information and experience as well as for discussing current issues and challenges. The results from surveys conducted among its members have become a recognized source of information for authorities, industry and other industry organisations. The Tool Box for QPs provides a compilation of tools like checklists, decision trees and workflows that could be used for structuring batch release decisions that would ensure all relevant points have been considered. The annually organised QP Forum is today’s principal meeting point for European QPs. This year the meeting will take place in Madrid, Spain, from 1-2 December – with three pre-conference workshops on 30 November (please see www.qp-forum.org for further information). There are also other education courses and conferences for trainee and newly qualified QPs organised and supported by the European QP Association in Europe and in the US.

A Good Practice Guide summarizes the responsibilities and duties of QPs in Europe and shows the various national requirements for becoming a QP. The exclusively developed shared audits database “QPSHARE” supports QPs in finding and contacting potential partners for sharing audits.

To find out more please visit the European QP Association’s website at www.qp-association.eu.

Wolfgang Heimes
Administration Manager
European QP Association
An Interest Group of the ECA Foundation
P.O. Box 10 21 68
69011 Heidelberg
Germany
www.qp-association.eu
info@qp-association.eu

This release was published on openPR.