11 October 2018 – GAMP COP Benelux celebrated its 10th anniversary
In 2008 a group of Computerized Systems Validation experts from Belgium and The Netherlands formally started a local ISPE GAMP® 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 focussing 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!
23 May 2018 – ISPE Belgium Affiliate Annual Meeting/Networking Event 2018
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 next upcoming events, followed by key note speech about GDPR.
Key note speaker:
"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, key note speaker Mr. Philippe De Backer - Secretary of State, and all attendees to make this event with networking reception successfully!
17 & 18 March 2018 - Belgium ISPE Young Professionals joined ISPE YP Hackathon in Rome
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 during 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!
Results ISPE Belgium Affilatie Board elections 2017
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 last survey questionnaire sent to all ISPE Belgium members in order to prepare its action plan for 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.
22 November 2017 - ISPE Belgium Seminar - Best Practices in Aseptic Processing
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, table top 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 cleanoom using VR glasses. Furthermore, it was again a great opportunity to connect to other industry members. Least but not least, several prices wera 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 about 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 2017 Europe Pharma 4.0 Conference - 23-24 Nov 2017 - Pescantina Verona, Italy
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.
ISPE Belgium Affiliate Board Directors Elections
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 afterwards 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).
15 June 2017 – Sterilization Seminar ISPE Belgium Affiliate & A3P Belgique
More than 100 Belgium professionals from Life Science industry joined the Sterilization seminar organised 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.
17 May 2017 – ISPE Belgium Affiliate Annual Meeting/Networking Event 2017
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 next upcoming events, followed by 2 key note presentations and a cocktail reception.
Key note speakers:
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, key note speakers and attendees to make this event successfully!
ISPE Belgium supported several Technical Meetings and/or Networking Events in 1sthalf of 2017
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.
23 November 2016 – ISPE Belgium Affiliate Seminar Biotech : Development & Operations
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, table top exhibitors, sponsors, speakers and all seminar attendees for a successful day.
11 October 2016 - GAMP COP Benelux “IT Infrastructure Qualification & Control in Life Science Industry”
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.
29 September 2016 - SIG Automation “Automation contractor management in pharmaceutical industry”
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.
22 September 2016 - ISPE Workshop : Isolation and Containment for Aseptic Processes and/or Potent Compounds Practices, Solutions and Developments
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 where demonstrated. A very appreciated beer tasting session closed the day.
18-21 September 2016 - ISPE Belgium Affiliate receives ISPE Affiliate of the Year Award 2016
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.
2 June 2016 – ISPE Belgium Affiliate Young Professionals Networking Event
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.
18 May 2016 – ISPE Belgium Affiliate Annual Meeting/Networking Event 2016
ISPE Belgium Affiliate Board presented some facts & figures related to ISPE Belgium Affiliate vzw/asbl during its Annual Meeting, followed by a Networking reception.
Mr. Wouter De Ploey, CEO of ZNA Antwerp was invited as key note speaker. He talked about “Banking and Health Care, what’s in common ?”.
26 April 2016 - Challenges of using Mobile Applications and Devices in Life Science Industry
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 world-wide, also for the Life Science Industry there is a hugh 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.
17 March 2016 – SIG Technology Transfer Workshop
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.
10 March 2016 – “Unleashing Innovation - When Pharma meets Technology”
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 key note, 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.