Regulatory Rapporteur

 

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September 2022 | Volume 19 | No.8

EDITORIAL

Regulatory operations: evolution and revolution

In this issue of Regulatory Rapporteur, our articles examine how changes in the regulatory operations field emphasise the requirement for regulatory professionals with a dedicated skillset, who can advise on, establish, and maintain systems that enable a company to retain critical documents in a controlled way.

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By Julie Warner and Vickie Goff

FOCUS

The changing role of regulatory operations

The role of the regulatory operations professional has and continues to evolve as the requirements for the position have changed drastically. This article discusses the regulatory process and technologies that operations professionals have and continue to adapt to, including electronic submissions.

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By Vanessa Phillips

FOCUS

How data remediation and stewardship is becoming the standard responsibility for regulatory operations professionals

There is an industry move towards a data-driven regulatory enterprise, highlighted through initiatives including digital application dataset integration (DADI) and electronic product information (ePI). This article discusses the importance of data excellence in the field of regulatory operations.

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By Jacci Squire

FOCUS

Streamlining regulatory processes when implementing new regulatory information management systems

In this world of data-driven decisions, having a regulatory information management system (RIMS) that sufficiently supports data capture and maintenance in an efficient way is becoming increasingly more critical. This article looks at how to implement a regulatory information management system, and the benefits of doing so.

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By Richard Bassett

FEATURE

Inclusion of older people in drug development and clinical trials: part 1

Too many clinical trials still did not include a representative number of older people, aged 65 and over, despite being the main users of medication. This article analyses if the publication of ICH E7 Q&A influenced the number of older people included in clinical trials.

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By Kajal Patel

FEATURE

EU reclassification regulatory framework: part 2

Rx to over the counter (OTC) switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or general shop without a prescription. This research investigates the challenges the pharmaceutical industry has faced with this process in the European Union and proposes where improvements could be made.

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By Sarah Laird  

FEATURE

Harmonising regulation of medicinal allergen products throughout the European Union

Historically, allergens were authorised under the national frameworks of member staters, with some legislation pre-dating the Treaty of Rome in 1957. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published a document on recommendations to common regulatory approaches for allergen products. This article provides an overview of the CMDh guidance.

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By Michael Edwards and Tanya Rackstraw