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Policy & Procedures

Publication policy and procedure consulting

Setting clear publication policies, standard operating procedures (SOP) and best practice guidance for your organization, based on Good Publication Practice (GPP) and industry standards, will empower your associates to take appropriate actions with ethical practices for publication planning and successful execution.

ASSESSMENT – of current Publication Policy & Procedures

UPDATES – of existing Publication Policy & Procedures

CREATION – of new Publication Policy & Procedures

Case Study

 

Situation:

Company desired to update their Corporate Disclosure and Publication Policy & Procedures to ensure alignment with current industry standards, guidelines, and regulations.  Policy needed to be aligned across all divisions within the company.

 

Solution:

  • Comprehensive assessment of company’s existing policy and procedures together with bench-     marking of publication policies of other major pharmaceutical companies.

 

Summary of assessment, identification of gaps, associated risks, and rationale for changes and recommendations to gain Senior Management buy-in and sponsorship of project.

  

  • Establishment of cross-functional and cross-divisional project team and Steering Committee.

 

Writing and development of updated policy with input and alignment from subject matter experts across all divisions within company.

 

  • Obtained approvals from all key stakeholders and Senior Management.

  

  • Development of communication and implementation plan across divisions, including internal communications from Senior Management for process change and implementation.

  

  • Developed & implemented training for worldwide associates.

 

 

Successful Outcome: 

Updated corporate publication policy aligned with current industry standards and guidelines was implemented and publicly released on company’s website. Company was able to ensure its associates involved with publications were adequately trained and informed of the updated policy and procedures. Company associates were able to utilize and share publication policy during discussions with clinical investigators.

© 2016-2017 Publication Practice Counsel; Truposha, LLC