ISPE France Affiliate: Long-Time Affiliate Continues to Shine

Since he first joined the France Affiliate in 2002, Duliere has been an active member of ISPE, serving on multiple local and international committees. During his long career as a production manager in pharmaceutical manufacturing, he worked in quality control, oral solid dosage form manufacturing, packaging, raw materials production from bacteria growth, industrial development, and dual-compartment syringe aseptic filling and as a consultant for an engineering company involved in many pharmaceutical projects around the world. Now 68, Duliere recently retired from his day-to-day job, but he continues to serve as the France Affiliate President, a position he has held since 2012. In April 2020, he was appointed ISPE’s European Regulatory Advisor.

Knowledge Sharing and Networking

Created in 1992 and established as a legal association in 2001, the France Affiliate is one of ISPE’s older European Affiliates. It primarily communicates with members in French and counts several French-speaking participants from neighboring Belgium and Switzerland among its 220 members.

“We try to hold our events in French,” said Duliere. “But when we have speakers from outside of France, our materials and presentations are in English. And while our work group meetings are in French, the groups produce written materials in English for publications such as Pharmaceutical Engi-neering®.”

Most Affiliate members work and reside close to France’s largest cities, Paris and Lyon. The Affiliate’s events are therefore centered around those two cities.

Duliere said the Affiliate strives to hold at least four events per year, typically in March, June, September, and November. The September event, he explained, is organized with Lyon University and held on the first day of the school year. Around 150 students come to see 30 industry professionals present on topics relevant to student interests, he said.

The other three events cover specific topics, such as GAMP®, computer systems, or serialization, and typically attract 30 to 40 attendees. “Through these events we try to grow the membership, but the main objectives are to share knowledge and have networking opportunities,” said Duliere. These one-day events include presentations on the topic of the day followed by a workshop session where attendees are divided into groups to discuss the topic and share their experiences.

Given the ongoing COVID-19 pandemic confinement and physical distancing measures, the France Affiliate, like others around the world, has had to adjust its 2020 event calendar. The Affiliate postponed some 2020 events and converted others to virtual meetings. Fortunately, the Affiliate already had experience with virtual meetings, as many of its committee meetings are held that way.

Committees

In 2006, the Affiliate initiated the GAMP® Francophone Community of Practice (CoP), a group working on subjects related to IT systems and guidance. “Our GAMP® Community of Practice is made up of a mix of experts and others with less experience who have come to be trained. In the last few years, they have been discussing topics like economic concerns, data centers, and agile methods,” said Duliere.

The GAMP® Community of Practice meets virtually every two months and usually holds two or three in-person workshops per year on current topics of interest.

In 2017, the Affiliate created a committee to address the impact of serialization on the organization of the supply chain and information systems. “For three years, the group published articles on best practices for serialization,” said Duliere. “However, following trends in European regulations and FDA documentation, this group shifted last year to focus on the consequences of the implementation of unique device identifiers (UDIs) for medical devices.”

The unique device identifiers committee meets virtually each month and face to face once or twice annually. “They hope to publish an article in Pharmaceutical Engineering® when they have finished their work,” Duliere said. The plan was to complete the unique device identifiers project in 2021, but Duliere now anticipates that the work will wrap up in 2022.

Challenges and Opportunities

Although the France Affiliate is running smoothly, Duliere acknowledges it faces some challenges, including member participation. “Members are not always involved in the life of the Affiliate, so we push to get them to attend our events,” he said. “More and more facilities in France belong to contract manufacturing organizations, and this is a challenge because, in many of these companies, the people are often not allowed to travel to go to such events.”

With that and other challenges in mind, Duliere welcomes opportunities to partner with other Affiliates. He participates in virtual meetings with other European Affiliates every two months, and the Affiliates get together in person each year at the 2020 ISPE Europe Annual Conference and 2020 ISPE Annual Meeting & Expo. “We are sharing best practices, what is working in each of our Affiliates, which topics to address at conferences, and developing a strategy for Europe for the future.”

Duliere also pointed out the Affiliate’s commitment to students and young professionals. In addition to the annual event at Lyon University, Affiliate board members participate in training sessions at pharmaceutical universities in Dijon, Lyon, and Paris, and the Affiliate has board members designated to the needs and activities of young professionals.