Globalization, Resource Constraints Top List of Regulatory Operations Concerns

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On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference speakers included a number of experienced directors and senior directors of regulatory affairs/reg operations from medium and large Pharma companies. During a panel discussion, an excellent question was posed: What are your biggest challenges – what keeps you up at night?

Although we received four different answers from the panelists, they all had a common theme: the impact of globalization and resource constraints on their ability to be successful.

The first panelist worried about how to staff and budget for global expansion (beyond US/EU/CA/JP). He identified the myriad of local format requirements and the need to work with local regulatory groups and consultants as concerns. He emphasized the need to think out plans and procedures before acting.

The second panelist also cited globalization, which for his company increased the need to work with partners and vendors, adding complexity and complications to existing processes. He found that globalization is changing his company’s regulatory strategy and increased the need to identify and comply with standards.

The third director mentioned that technical issues such as Regulated Product Submissions did not concern her. Instead, she identified the impact of the poor economy, which results in both resource constraints and requests for greater speed. She finds her group to be very resource constrained, and is concerned that if she adds temporary help, she may not be able to train them quickly enough for them to take on major responsibilities.

Finally, the fourth director noted that lack of alignment between business and IT was creating a major risk. For example, the business is placing a high priority on expansion into additional countries and regions – but IT does not have the necessary software upgrades in their work plan. Due to resource and funding constraints, IT is being driven to minimize upgrades while the business wants new features that will increase their efficiency due to their reduced or frozen headcount. He sees more and more a discrepancy between what the business needs and what it is possible for IT to do.

I’m grateful for the willingness of the panelists to share their thoughts and concerns, which was very useful to me in understanding the current business climate. I would be interested in your thoughts about this topic, which results in challenges for most of us connected with this business in any capacity.

Author: GS

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