Evolving Roles for Submission Managers The field of submission or dossier management has changedsignificantly in recent years. New electronic submission requirements,new technologies and varied agency implementation schedules for eCTD(electronic Common Technical Document) have added complexity andconfusion to the submission management process. These factors havealso changed the role of the submission manager and the skill setsrequired to be successful at submission management. This paper willdiscuss the changes that have occurred and how they impact theoperational aspects of good submission management.
Content Plans This white paper explores the benefits afforded an organization in using an accurate content plan, the challenges organizations may face in implementing and maintaining a plan, and finally a few ideas to consider in developing a good content plan.
The Critical Path Conundrum Webster’s dictionary defines a conundrum as “a question or problem having only a conjectural answer; an intricate or difficult problem; a mystery”. American Heritage Dictionary asserts that a conundrum is “a paradoxical, insoluble, or difficult problem; a dilemma”. This white paper explores the biopharmaceutical industry conundrum and the confluence of four key industry catalysts that will help solve the dilemma: evolving standardization, process synchronization, performance optimization and electronic transformation.
Authoring Practices for Submission Documents With so many variables affecting the process, it is important to start with the basics to ensure that your submission documents are created with minimal pain and maximum efficiency. This white paper discussed several basic principles at the core of submission document authoring.
Best Practices in Electronic Submission Management The assumptions that guide the way industry approaches electronic submission management are changing. The common vocabulary of submission management is evolving and business processes are being redefined. This paper discusses the initiatives underway to meet new submission management goals once thought impractical, or even impossible just a few years ago.
Making the Leap Into Electronic Submissions: How to Introduce New Technology Successfully How do you know it is time to invest in new eSubmission technology? Or what signs should you look for that your existing systems are failing to deliver all that they should? Review the following common characteristics and consider how many apply to your organization. If more than one or two strike a chord, it is probably time to take action.
