GAMP CoP Benelux invited Mr. Bill Bellows, Ph.D. (Deputy Director, W. Edwards Deming Institute, USA) for a keynote speech and interactive discussion about "quality" as enabler for organizations working in a collaborative environment. Furthermore there were presentations about data quality coming from last published industry (GAMP RDI Good Practice Guidance - Key Concepts) and regulator guidances (PIC/S), and about using system life cycle documentation management tools in Life Science industry.
Thanks to Sanquin as host/sponsor, all steering committee members, speakers and attendees to make this event succesfully.
ISPE Belgium recently established a new local SIG on “Pharma 4.0 @work”, covering the current Industry 4.0. challenges in Pharma. Given the fact that Automation and Industry 4.0 are “converging”, the board of ISPE Belgium decided to transform the former SIG Automation into this new SIG. Jacques Godelaine from GSK and board member of ISPE Belgium, is leading the ISPE Belgium SIG Pharma 4.0. @work.
Interest to join the monthly after-work roundtable discussions of this new SIG?
More info and contact details: https://ispe.org/belgium-affiliate/communities-practice
Top speakers from academia and industry shared their insights about the digital (r)evolution in the Pharma industry and presented case studies about data analytics, big data, manufacturing 4.0., robotics, etc. On top of that, Janssen Pharmaceutica selected a site visit tour seeing how J&J is stepping ahead.
More than 100 delegates joined us during ISPE Belgium Affiliate Seminar 2018 with a tabletop exhibition and networking reception (sponsored by Janssen Pharmaceutica).
Thanks to all speakers, tabletop exhibitors, host/sponsor, and all delegates.
In 2008 a group of Computerized Systems Validation experts from Belgium and The Netherlands formally started a local ISPE GAMP® Community of Practice (CoP). During the last 10 years, they organized local events, always bringing people together discussing hot industry – GAMP® related - topics. They are globally embedded in a strong ISPE GAMP network and are the most active ISPE Community of Practice for Life Science industry professionals in Belgium and the Netherlands.
On 11 October 2018 in Brussels, GAMP COP Benelux celebrated its 10th Anniversary during a full-day seminar with lessons learned, case studies, sharing experiences and inspirational speeches about GAMP 5 framework, Computerized Systems Validation, Digital Health, Manufacturing 4.0, Data Privacy,...
The GAMP® 5 principles and concepts are still relevant focusing on quality and supporting innovation and digital technologies, where currently scope is definitely more than only automated manufacturing processes and business challenges driving us to more collaboration and smarter compliance.
Thanks to all the steering committee members, sponsors, speakers, attendees to make this event, including networking drink and 10th Anniversary dinner successfully!
We were happy to welcome our ISPE Belgium Affiliate members, also the ISPE Belgium Young Professionals community, during ISPE Belgium Affiliate Annual Meeting & Networking event on May 23rd in Brussels. This after-work event started with a short overview of ISPE Belgium Affiliate's activities and the next upcoming events, followed by keynote speech about GDPR.
"GDPR, the new Data protection regulation”
(Philippe De Backer, Secretary of State for Social Fraud, Privacy, NorthSea - Former member of the European Parliament)
We would like to thank all our sponsors, keynote speaker Mr. Philippe De Backer - Secretary of State, and all attendees to make this event with networking reception successfully!
A delegation of Belgian ISPE Young Professionals were represented at the ISPE YP Hackathon organized in Rome during the weekend before the ISPE Annual Europe Conference started. During the Hackathon, YP had to team up for 24 hours to come up with a business case to invest in Pharma 4.0 technologies of the future. On Sunday afternoon, they presented their ideas to the ISPE Global Pharmaceutical Manufacturing Leadership Team.
Great opportunity to engage with the YP community across Europe and be part of the paradigm shift in the pharmaceutical industry. Intrigued and interested in participating in next year's YP Hackathon? Sign up to become a YP ISPE member and join us in the 2019 edition! See you there!
During ISPE Belgium Affiliate Board Meeting in December 2017, the outcome of the statutory voting ballot for a new Board of Directors for the ISPE Belgium Affiliate for the period 2018-2020 was presented and the Board Officers positions are appointed. The Board also discussed the results of the last survey questionnaire sent to all ISPE Belgium members in order to prepare its action plan for the next coming years to further improve and support the Belgium pharmaceutical industry.
All the outgoing board members were thanked for their participation and support. There was a special message from John Bournas, ISPE CEO and President, for Jef De Clercq, Jean-Jacques Follebouckt, Leo Versteynen and Jan Huybrighs for their volunteer leadership role for more than 20 years to make ISPE Belgium Affiliate successfully.
On November 22th, ISPE Belgium Affiliate held successfully its Seminar at Technopolis - Mechelen, this year about Best Practices in Aseptic Processing - Challenges, Solutions and Site Visits, with Table Top exhibition and site visits at Alcon and Pfizer plants in Puurs. Presentations and case studies were coming from A3P, Pfizer, GSK, Novartis, J&J and Parker.
We would like to thank all attendees, speakers, tabletop exhibitors, sponsors, Alcon and Pfizer.
9 November 2017 – Belgium Young Professionals event: Cleanroom qualification and virtual simulation
On November 9th, a Young Professionals event was organized at Advipro, Lille. Industry experts from Advipro and Quat! gave interesting insights into cleanroom qualification and virtual simulation. The presentations ware followed by several workshops around related themes, like smoke studies or HVAC installation. Some of the highlights are the following: we got the opportunity to enter into the new grade C cleanroom and assess the impact on particle generation, a look behind the scenes of the cleanroom and its HVAC installation and walking around in a virtual simulation of a cleanroom using VR glasses. Furthermore, it was again a great opportunity to connect to other industry members. Least but not least, several prices were raffled like VR glasses and an ISPE membership. In conclusion, a great and instructive evening.
10 October 2017 – GAMP COP Benelux event: Computerized Systems & Data - eClinical
GAMP COP Benelux shared best practices with peers and discussed cloud solutions, data privacy, data governance, validation challenges during 1/2 day event about Compliance Challenges eClinical Computerized Systems & Data at Qbd, Wilrijk (Belgium). Expert speakers from GAMP D-A-CH joined us during this event.
ISPE in Europe has founded a new Special Interest Group (SIG): “From Industry 4.0 to Pharma 4.0“. The Pharma 4.0 SIG initiated discussions around the concerns that the automation factors are causing in production. It is a complex pharma challenge and the goal is to specify Pharma 4.0 and to differentiate it from the common “Industry 4.0“ concept, with the focus on maturity level models integrated in the programme.
ISPE Pharma 4.0. SIG invites you to its Europe Pharma 4.0. Conference.
As an official non-profit organization according to Belgian legislation, governed through the bylaws, the ISPE volunteer code of conduct and the ISPE Belgium Affiliate Guidelines, the next upcoming ISPE Belgium Affiliate Board Directors elections will be announced soon. Each ISPE Belgium Affiliate member will receive a personal e-mail requesting for candidates, and afterward a personal e-mail for voting. The Board Directors (max. 20) are representing officially the ISPE Belgium Affiliate organization. Please check (and update if required) your contact details (email address, company,…) via ISPE Membership; My Account. (login required).
More than 100 Belgium professionals from Life Science industry joined the Sterilization seminar organized by ISPE Belgium Affiliate together with A3P Belgique. Various speakers from industries presented case studies, representatives from the Belgian Federal Agency for Medicines and Health Product and Table Top exhibitors were present. In the afternoon there was a site visit to the Shire Lessines Glassia Building.
Almost 100 ISPE Belgium members are joining us during Annual Meeting & Networking event on May 17th in Brussels. This after-work event started with a short overview of ISPE Belgium Affiliate's activities and the next upcoming events, followed by 2 keynote presentations and a cocktail reception.
Pharma in Belgium: a laboratory of hope for patients worldwide”
(Catherine Rutten, CEO at pharma.be - Belgium Federation of the Pharmaceutical Industry)
“The future of (bio-)pharma operations“
(Paul Rutten, Partner, Leader of McKinsey's Quality, Compliance and Remediation practice)
We would like to thank all our sponsors, keynote speakers and attendees to make this event successfully!
The ISPE Belgium local SIG/COP groups organized several technical meetings/workshops, combined with networking opportunities. More than 150 participants participated in 1 or more events. ISPE Belgium welcomed some new ISPE members during these events. A new local Special Interest Group about Operational Excellence was launched on February, 10th.
Around 100 participants gathered for ISPE Belgium Affiliate’s 2016 seminar on Biotech - Development and Operations at Kinepolis Imagibraine. During two parallel work streams (Development, Operations), speakers and attendees shared lessons learned and best practices from the industry. Several Table Top exhibitors presented their products and services. The day was concluded with a very interesting site visit at the nearby located facilities of UCB and with a networking reception.
ISPE Belgium Affiliate would like to thank UCB, tabletop exhibitors, sponsors, speakers and all seminar attendees for a successful day.
GAMP COP Benelux organized a ½ day event, hosted by Ordina. Around 50 attendees coming from Belgium and the Netherlands were present. Presentations, case studies and round-table discussion about current trends in IT Infrastructure Qualification & Control were really appreciated.
The Special Interest Group (SIG) on Automation held a technical meeting, hosted by UCB Braine l’Alleud. Around 20 enthusiastic participants representing pharmaceutical manufacturing companies and automation contractors shared new technical and organizational challenges and best practices. We had an excellent mix of participants from Actemium, Agidens, Alcon, Biocartis, DPS Engineering, Emerson, Fujirebio, Genzyme, GSK, J&J, Pfizer, Siemens, Shire, and UCB.
During the meeting, interesting topics were discussed: automation technology benchmark, integration with IT world, automation partners management (OEM, integrator, automation provider, consultancy). After the meeting, a site visit was organized on UCB B4 packaging plant.
Next SIG Automation meeting is planned in Spring 2017 at Shire in Lessines. More details will follow.
More than 50 pharmaceutical and biotech professionals, coming from the Netherland, Switzerland, France, and Belgium, gathered in Gembloux (BE) on September 22 to listen to - and exchange with - 6 high-level experts originating from Germany, Switzerland and Belgium about isolators and containment. This very fruitful day was followed by the visit of the Aseptic Technologies SA workshop, where leading-edge Closed Vial® filling equipment and original product transfer systems were demonstrated. A very appreciated beer tasting session closed the day.
During ISPE Annual Meeting held on 18-21 September 2016 in Atlanta (USA) the Belgium Affiliate was honoured by receiving the "Affiliate of the Year Award” for outstanding work in 2016 particularly in the areas of membership development and supporting young professionals.
During ISPE Annual Meeting in Atlanta (Sept 2016), the Belgium Affiliate received the Affiliate of the Year Award. Belgium Affiliate Chair Jef De Clercq accepted the award on behalf of the Affiliate.
The ISPE Belgium Affiliate Young Professionals Board welcomed 70 participants during its first Networking event with the inspirational title “Get to know your playground”. Join ISPE Belgium Young Professionals LinkedIn group.
2 June 2016 – ISPE Belgium Affiliate at BCW College Day 2016
ISPE Belgium Affiliate was present during BCW College Day 2016 at Flanders Expo Ghent. Belgian Cleanroom Workgroup (BCW) is a non-profit cleanroom society providing knowledge, networking and training. More than 125 participants and 25 table top exhibitors joined this event and shared knowledge about cleanroom technology and contamination controls. Get more information on Belgian Cleanroom Workgroup.
ISPE Belgium Affiliate Board presented some facts & figures related to ISPE Belgium Affiliate during its Annual Meeting, followed by a Networking Reception.
Mr. Wouter De Ploey, CEO of ZNA Antwerp was invited as keynote speaker. He talked about “Banking and Health Care, what’s in common ?”.
On 26 April 2016 GAMP COP BeNeLux organized a ½ day event at Actemium, Veghel (NL) with more than 35 delegates. Actemium presented a demo, UCB and GSK presented case studies about validation of mobile (medical) apps and development of mobile apps for clinical studies. Mobile application and devices are used worldwide, also for the Life Science Industry there is a huge opportunity to implement if we understand and tackle the (potential) compliance risks. GAMP COP BeNeLux would like to thank Actemium, all speakers and all delegates to join us.
More information about GAMP Good Practice Guide about Regulated Mobile Applications.
On 17 March 2016, the Special Interest Group Technology Transfer held its first Workshop at UCB in Braine l’Alleud. 18 attendees from the major pharma companies in Belgium were present during an intensive afternoon to exchange their experiences and benchmark their approaches for market access technology transfers. Case studies were presented by guest speakers from Bilthoven Biologicals, Intravacc and GSK Vaccines.
On 10 March 2016, more than 250 professionals from the life science and technology industry met each other during an event in Brussels ‘Unleashing Innovation: When Pharma meets Technology “, organized by Agoria, Pharma.be and ISPE Belgium Affiliate. www.unleashinginnovation.be
Two hot topics of interest “Pharma Factories of the Future” and “Digital Health” were discussed in parallel tracking sessions.
ISPE Belgium Affiliate was proud to have John Bournas (President & CEO, ISPE) as keynote, together with Dr. Thomas Zimmer (VP European Operations, ISPE), Gert Moelgaard (Moelgaard Consulting and Member of ISPE Facilities of the Future Strategy Team) and Marc Sohet (Former VP GSK Vaccines ) as speakers for the track “Pharma Factories of the Future”.
Attendees also appreciated the networking opportunities by visiting the Technology Village, a minifair with technology showcases, and participating the face-to-face meetings via matchmaking application Conversation Starter.