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How Digital is Elevating Regulatory Affairs: Summit Day 3 Recap

Day three of the 2022 Veeva Industries Virtual Summit focused on regulatory management, with topics covering issues such as handling regulatory demands and the role technology plays in that process. The Summit also provided participants with the opportunity to connect with their peers in live demos and industry roundtables, discuss industry-specific topics, expand their network, and connect 1:1 with Veeva’s product and services team members.

Topics for the day three sessions included:

  • A Journey of Regulatory Affairs Transformation
  • Who's Your Regulator? Addressing the Disparate Needs of Compliance Stakeholders
  • Trust and Transparency

Key Industry Speakers

Speakers for today’s sessions included leaders in regulatory management from some of the world’s most prominent organizations in industries such as chemicals, consumer products, and food & beverage. Featured speakers for day three of the Veeva Industries Virtual Summit were:

Read on for highlights from each of today’s sessions. 

Session 1: A Journey of Regulatory Affairs Transformation

Suzanne Lingard, Vice President of Regulatory Affairs and executive committee member at FMC Corp., addressed the transformation FMC has undergone over the past few years. Lingard had spoken with Veeva two years ago and talked about how sustainability was at the heart of that transformation.

“We've built a connectedness and agility into business and response to our customers,” Lingard said. 

“We have developed very ambitious sustainability targets, and we're developing and putting into place the actions to support both the short-term and long-term goals,” she said. “We're continuing to drive innovation in our portfolio with an absolutely fantastic R&D team.” 

FMC also has a Ventures team that continues to evaluate new technologies that might fit with its sustainability and future business goals and fit into the changing crop protection landscape. 

“Through all of that, though, supporting business growth and all of these endeavors across different areas requires our regulatory function to continue on a path to greater efficiency and agility and making sure that we're supporting our internal and external customers effectively,” Lingard said. “One of the ways we’ve continued to do that is through the Veeva RegulatoryOne Platform.”

Hear the full conversation on-demand by registering for or logging into the Veeva Industries Summit.

 

Session 2: Who's Your Regulator? Addressing the Disparate Needs of Compliance Stakeholders

Regulatory authorities can make or break businesses across industries, and announcements can shake markets. A company will fail or thrive according to its ability to quickly move new products or ingredients through regulatory approval processes. 

Veeva’s regulatory software is designed to achieve the critical goal of accelerating the agency approval process for new consumer products and chemicals. Each product category has unique considerations when it comes to the protection of consumers, businesses, and the environment. And this leads to an engagement with a much wider array of competent authorities and with more departments, even within those authorities. Companies must consider and embrace an array of stakeholders, and their power and relative influence is constantly evolving and fluctuating. 

To kick off the session, panelists discussed the top three stakeholders they needed to be concerned with when doing their job and leading their organization.

“Picking a top three is very difficult, but if you twisted my arm, I'd have to say number one would have to be the competent authorities,” Dr. John L. Hott, Ph.D., President of the Product Stewardship Society said. “The remaining two would be our customers, which include everyone along the supply chain, including retailers. Rounding up the top three would be investors who are making the decision to place their confidence in our company by buying or selling our stock.”

Lisa Pankiewicz, Vice President Global Stewardship at The Clorox Company echoed much of Hott’s sentiments.

“For my team, I would say our regulatory authorities, our legislators, and our non-governmental organizations,” she said. “There's little coincidence that John and I both see regulatory agencies as our top choice. The truth of the matter is that our regulatory authorities, be it in the U.S., Europe, or Latin America, really create the baseline for compliance and really drive our work.”

Additionally, when considering the current regulatory landscape, consumers are relying on other stakeholders to help strive for compliance, Pankiewicz said, while NGOs and legislators are both competing to be the voice representing the consumer.

“My top three are very similar to John’s and Lisa’s, with government authorities being at the top of the list,” EJ Glaza, Director Global Regulatory Affairs at Amway said. “When working with authorities globally, I find it very important to know and understand what is at the center of that country's regulators' agenda, especially when you're trying to interpret the meaning of new regulations or even answering questions during complex registrations.”

When it comes to NGOs, much of their demands are coming via social media outlets, adding additional complexity, Glaza said. And for Amway, the third stakeholder is the independent business owner who depends on the parent company to ensure that the products they sell are compliant.

To see the rest of this panel conversation, please register or login to watch the session on-demand. 

Session 3: Trust and Transparency

Trust is the new consumer currency, and transparency truly underpins that. But when it comes to products, transparency is an easy promise and a very challenging reality because chemistry is messy, formulations are complex, and product stewards must be data detectives. Stewarding products end-to-end engenders trust and drives growth, but critical data is often missing, dated, or inaccessible.

People are very much in touch with consumer brands, but the reality is that specialty chemicals drive so much technical innovation. And when it comes to stewarding products end-to-end across the value chain, communication difficulties often hamper progress.

“It's also a bit of a different context in Europe because, from a regulatory perspective, there are 27 countries with different regulations,” Dr. Adrian von Mühlenen, Product Owner Digital Material Passport Catena-X at BASF said. “We can’t just take the same product and ship it [to every country]. We have to go through the entire formulation and see if there is any kind of banned substance for that given country.”

Often, companies deal with languages and other communication barriers that must be overcome.

“For us as a global company, it's challenging because not everybody speaks the same language,” Jennifer Chittick, Director of Product Safety and Toxicology at Cabot Corporation said. “You have those types of barriers, but also, in some instances, the data doesn't exist. That puts pressure on the supply chain when information is not readily available when you need it.”

A lack of digitalization is a barrier as well, von Mühlenen said. “We might get the SDS on paper, or we get a PDF; it's still a paper because it's not a machine-readable format,” he said. “We have to go first of all through it and see if we trust this information, and then we have to type in the information in our system.”

There might still be information lacking, so a supplier questionnaire is sent out, followed by a phone call to go through it point by point.

Tomorrow’s Sessions: Advertising and Product Claims

The final day of the Veeva Industries Virtual Summit will engage participants on topics related to Advertising and Product Claims, with sessions covering claims management for innovation and growth, and the risks associated with sustainability claims.

View the full agenda, reserve your spot, and access recordings of the sessions here. There is no cost to attend.

Veeva Industries

Posted by Veeva Industries

Veeva builds industry cloud software to help consumer goods and chemical companies bring innovative, high quality products to market with more agility.