How Do RA Professionals Manage Complexity and Bureaucracy at a Local and Market Level?

Narrow focus vs Global strategy concepts

How to transform Regulatory Affairs to manage the increasing complexity of organisational growth?

• Frame this around outsourcing; upscaling based on the maturity of the client
• Does a company have ‘scalability’ built into its plan?
• CROs provide a reactive solution whilst a company looks to increase current resources…and give a more flexible option
• There is a definite trajectory in a company when they start to ‘grow’, from typical multi-hat-wearing departments to a streamlined matrix organization with discrete functional roles
• Focus on RA processes
• From Documents to Data…and an increase Digitization….move away from paper-based
• Allow a greater geographic spread of personnel as all now have access to the ‘same’ data
• Global Dev perspective
• Narrow focus vs Global strategy and not having harmonized data and ultimate impact on costs i.e. LCM, Safety etc.
• Businesses becoming more compartmentalized i.e. Submission managers, giving oversight, sitting outside of the traditional functional area ….and only coordinating
• Companies are adapting and evolving
• Global/local organization leads to collaborative and efficient systems….at a global level!
• Historic setup can limit visibility for affiliates but digitalization leads to greater oversight at a global level and allows for a greater spread of personnel in varying geographic regions

How do you see future importance and responsibilities of regulatory affairs in the pharma industry?

• RA will always have a place in the industry
• Regulations and legislation are always evolving with increasing complexity and bureaucracy both at a local/market level but also pan-EU and globally
• There is an ever-increasing need to have RA professionals who are linked to this and can advise the company both in the pre-submission and post-approval space
• From post-Brexit mitigation, a focus on environmental updates with e-PIL and waste packaging management, to the management under new MDR and Sterilization requirements to global initiatives such as Project Orbis and the Access Consortium (to name but a few), RA has a hugely important role in keeping its finger on the pulse to ensure that a company maintains its compliance against current and future rules and regulation!
• RA are the intermediary between the company, Health Authorities and Governing bodies and supports a much broader capacity in terms of lobbying and influencing the chance to best support the industry
• Horizon scoping is paramount and needs to be embraced to ensure that ‚companies and manufacturers are not left behind and that change is approached in a planned and controlled way ensuring the smooth transition and implementation in the past

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ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.

Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 140 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access (pricing & reimbursement), vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.

With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

For more information, visit productlifegroup.com

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