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Optimizing Regulatory Strategy Workshop for Micro, Small and Medium Sized Enterprises, EMA 26 May 2011 Presented by: Aide Friars Head of Regulatory Affairs, Main agency of the European UnionEvolving

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What is optimising regulatory strategy?

Optimising regulatory strategy refers to the process of developing and implementing a strategic approach to ensure compliance with regulatory requirements while maximizing operational efficiency and minimizing risks.

Who is required to file optimising regulatory strategy?

Companies operating in regulated industries, such as pharmaceuticals, healthcare, finance, and telecommunications, are typically required to develop and file an optimising regulatory strategy to ensure compliance with applicable regulations.

How to fill out optimising regulatory strategy?

Filling out an optimising regulatory strategy involves conducting a thorough assessment of regulatory requirements, identifying potential areas for improvement and efficiency gains, developing appropriate compliance policies and procedures, and regularly reviewing and updating the strategy to reflect any changes in regulations or business operations.

What is the purpose of optimising regulatory strategy?

The purpose of optimising regulatory strategy is to ensure that companies meet all relevant regulatory requirements in a cost-effective and efficient manner, while also minimizing risks associated with non-compliance and potential penalties.

What information must be reported on optimising regulatory strategy?

The specific information required to be reported on an optimising regulatory strategy may vary depending on the industry and applicable regulations, but typically it includes an overview of the regulatory landscape, a risk assessment, a compliance plan, and a timeline for implementation and review.