Creating structures and standards in regulated industries

Stacey Lewis Date published: Jun 21, 23

Creating structures and standards for highly regulated industries such as pharmaceutical and biotechnology can be very challenging. It's like trying to build a plane while you're flying, navigating the fast-paced and competitive landscape while striving to bring critical therapies to market.

In our recent medical and regulatory writing webinar masterclass, "Creating structures and standards: Building the plane while flying," industry experts Abigail Shetler, ELS, Executive Director of Wordsmith Medical Writing LLC, and Faruk Pasic, ELS, Medical Writing Operations Specialist, formerly of Takeda Pharmaceuticals provided valuable insights and recommendations for improving processes while maintaining business operations.

In case you missed it, here are some key points discussed during the webinar.

Navigating the roadblocks: Key variables impacting process improvement initiatives

Abigail and Faruk emphasised the importance of recognising the variables that affect process improvement initiatives. These variables include:

• Limited existing structures and standards
• Staffing challenges
• Limited personnel training opportunities
• Resource constraints

Abigail highlighted, "Small to medium-sized, and large organisations alike, can struggle with limited structures and standards. It's crucial to address this challenge for effective process improvement."

Building the plane…

To explain the concept of building the plane, our expert speakers drew parallels to our day-to-day work. They emphasised the significance of structures, standards, and processes as the building blocks for improvement. Structures encompass the organisation of personnel and the distribution of roles and responsibilities.

Standards and processes involve:

• Standard operating procedures
• Job aids
• Style guides
• Templates
• Checklists
• Document review platforms
• Effective communications

"These building blocks lay the foundation for efficient and organised operations."- Faruk Pasic.

Challenges and considerations

At times we all need a reality check when considering process improvement. After all, it can often be more challenging than it seems.

It is essential to consider team size, skill sets, and unique strengths while assessing the appropriateness of the structures and standards. Collaboration and buy-in from team members and external stakeholders were highlighted as essential for successful organisational changes.

Abigail added, "Involving people in the process and making them feel valued leads to a smoother transition."

Standardising processes in document development and team communications

Abigail and Faruk touched upon the document review process, quality control, and the publishing and submission steps in medical and regulatory writing.

Through highlighting the limitations of relying solely on emails for communication, it is recommended to consider developing a communication strategy, including standardising messaging and processes for internal and external communications.

They explained that it's crucial to define the workflow for authoring, reviewing, editing, formatting, and publishing documents by pushing the importance of accuracy, proper citation, and adherence to style guidelines during the review and editing stages.

Implementing changes

Abigail and Faruk stressed the importance of implementing changes slowly and thoughtfully. It's crucial to manage the pace of change to avoid overwhelming team members who may be resistant to change.

Prioritising the most impactful changes and spacing them out over time ensures a manageable transition. Faruk emphasised, "By taking a step-by-step approach and keeping the big picture in mind, organisations can achieve successful process improvements."

…While flying

The webinar provided valuable insights into creating structure and standards while managing ongoing operations. Abigail and Faruk highlighted the significance of assessing team dynamics, involving stakeholders, implementing changes thoughtfully, and considering the big picture. Also, the need to identify and establish efficient document development and team communication processes. Standardisation, visual presentation of data, and cross-functional collaboration are key elements in improving productivity and quality within an organisation.

By addressing these considerations, organisations can lay a strong foundation for process improvement and achieve long-term success.

Fueling growth

This is just a taste of the valuable knowledge shared by our esteemed speakers during our medical and regulatory writing masterclass on creating structure and standards.

Creating structures and standards is a challenging task. Still, with careful planning, collaboration, and a focus on the big picture, organisations can overcome obstacles and achieve efficient and organised operations. This in turn leads to improved productivity, streamlined processes and greater overall success.

Medical and regulatory writing masterclass series

As we delve into the intricacies of the document review process in the medical and regulatory writing industry, we invite you to stay tuned for our upcoming series of informative masterclasses. Keep an eye out for future sessions that will expand your knowledge and expertise.

Watch the on-demand webinar

Why not explore the full webinar for a more in-depth understanding of the insights shared by our expert speakers.

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