Upgrading your protocol writing skillset: best practice insights for protocol development 

Jonathan Mackinnon

The skillset of medical writers is constantly evolving. Influences from patient centricity, trial complexity, technology, and project management mean that we’re now expected to bring more skills than ever before to our daily work. We are no longer “only” expected to author the protocol by capturing the decisions of a small team of contributors, rather incorporate multiple fragmented information streams, balance complexity with clarity, understand and implement technology, and manage increasingly complex team structures.

The webinar will provide an overview of the current best practice techniques used by a global medical writing team to handle these new and growing challenges. The learning objective of the webinar is to provide guidance and methodology to help medical writers approach contemporary protocol development.

Level: Intermediate/advanced

Previous knowledge required: General protocol structures/content, familiarity with developing protocols or regulatory documents, ICH E6(R3), ICH E8(R1).