Euro Convergence: Experts agree regulatory affairs is both science and art

BERLIN – Is regulatory affairs science or art? Experts considered that question as they kicked off the 2024 RAPS Euro Convergence conference plenary session on Monday, during which panelists presented various pieces of art and drew parallels between the art and their experiences in regulatory affairs.

Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD, and Gert Bos, executive director at Qserve, moderated the panel. They presented artworks, such as Claude Monet’s painting Lady in the Garden and Edgar Degas’ L’Orchestre de l'Opéra, which the panelists said could represent the various parties, such as industry and regulators, working in harmony to bring treatments to patients.

L’Orchestre de l'Opéra was selected by Flora Giorgio, head of unit at the European Commission, who could not attend in person. Instead, Bos gave her presentation, stating that the musicians, instruments, and dancers in the art piece could be seen as the regulatory players and industry working together to fine-tune and produce music and performance for patients and healthcare providers represented by the orchestra audience.

“The orchestra is not only producing music, [which is] like the regulatory decisions, guidelines, and certificates, but it also enables the ballerinas to dance, and it enables the spectators to enjoy the show,” he added. “You do not see the conductor, but they must be there to ensure everyone plays in a coordinated and harmonic way, though they are not at the center of the scene.”

Bos also noted that the orchestra requires numerous stakeholders responsible for elements such as sound, light, and choreography, who are not visible in the piece, but are equally important. In the regulatory realm, those stakeholders would include competent authorities, notified bodies, designated authorities, the European Commission, and other experts playing their part.

“But only if they play in a coordinated way, the result is a success,” said Bos. “They need training, they need time, they need connections, including emotional connections. It also means they need empathy to enable the musicians to play together and people working together over hours of practice sessions to enable that final show for the benefit of patients.”

Bodo Mestmacher, TIC Manager MDR at TÜV NORD CERT GmbH, presented Derek Curtis’ To Infinity And Beyond. He said that he’s watched as regulations in Europe have evolved since the 1990s and opined that the field contains elements of both science and art.

"The science part of it is to collect the information and compile it into documents that are submitted for registration purposes, for postmarket surveillance and other purposes,” said Mestmacher. "The art part is about how to compile the documents, data, and facts. It should introduce you to the data and facts and tell you a story.”

“Of course, we need an artist who is the regulatory affairs professional who prepares the documents, taking all the elements that are available ... and make it ready to understand,” he added.

Mestmacher noted that while regulators typically expect very colorful art pieces that tell the story of how a product was developed and how it will affect patients, they are sometimes faced with art pieces with blank spots that fail to tell the whole story.

"Is regulatory affairs a science or an art?” asked Elizabeth Gfoeller, corporate director for regulatory affairs at MED-EL. “I agree completely with Bodo, it is both. Sometimes it is more science and at others it is more of an art form."

While the rules, guidelines and other documents are based on hard science, she noted that regulatory professionals have to use a lot of "artful skill" on a day-to-day basis to get products to market.

Jasmin Barman-Aksözen, a patient advocate for the International Porphyria Patient Network (IPPN), was also a panelist. As a patient with porphyria, she presented a photo of herself, which she said was helpful in persuading the EU to approve a treatment for her disease a decade ago as the first patient advocate participant in the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

While regulatory professionals can trust data and science to make decisions, Barman-Aksözen said sometimes art could help fill in the gaps that science can’t elucidate.

"Pictures, and art in general, can [convey] information that is not captured by science,” she said. Ultimately, she added that the future will involve more patient engagement in medical products development.

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Euro Convergence: Experts agree regulatory affairs is both science and art

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