Registration timeline

The best advice on press releases may be twofold. First, avoid scientific nuance and technical detail. State clearly whether or not the primary objective of the clinical trial was met. Whichever the case, then state clearly the implications of these data to the clinical development plan if it needs redirection, the state what that redirection is, and the implication for the registration timeline. 

Then, consider that any occupational accident is reported and recorded. Typically, the registration and reporting forms of occupational accidents contains the accident date and the duration of the recovery period following the accident. This information, in addition the admission and dismissal dates, sets the timeline for each work as illustrated in Figure 1. 

Figure 5 shows the development timeline of ISO 16505. After the New Work Item Proposal was submitted, it took five years before the International Standard ISO 16505 was published. After registration of the Final Draft International (FDIS), the project faced a delay of approximately 6 months before the FDIS ballot was started because several formal and editorial questions had to be clarified. 

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