Product Approvals in Asia

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If we put enough resources into this and got aggressive with our timelines getting approval would not be a problem. It all comes down to focusing D&R efforts on development and providing support to our colleagues overseas in a timely manner with their requests.

A two day conference in Rochester with presentations by the department heads and key project team members would help get things focused and bring a lot of ideas to the table as to how to address critical path items (more people on each critical path item, more % time trying to reduce the time of completion of the critical path item)

If this conference was chaired by the CEO things would get done and our products would get approved in Asia faster.
 






Getting regulatory approval for our products in countries like Japan are HUGE for the profitability of this company.

A company wide conference on how to make these approvals happen should help.
 






























Anonymous said:
Does anyone expect product registrations with such a high employee turnover rate within the regulatory departments?
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Not an excuse. All of the people that need to give the project managers reports for these projects need to speed things up. Management will worry about the resource allocation in regulatory to make this happen.
 






Getting regulatory approvals in Asia is highly dependent on the quality and strength of the submission package. The quality and strength of the submission package is highly dependent on the quality of the the work from ROC R&D and Medical / Clinical Affairs. The quality of the work from these groups is highly dependent on the leadership from the VP's running the show. The buck stops with the VP. Now you know why there are very few new products approved in Asia. These groups need to be overhauled if Bausch has any hope of ever being competitive with the big boys.
 






Anonymous said:
Getting regulatory approvals in Asia is highly dependent on the quality and strength of the submission package. The quality and strength of the submission package is highly dependent on the quality of the the work from ROC R&D and Medical / Clinical Affairs. The quality of the work from these groups is highly dependent on the leadership from the VP's running the show. The buck stops with the VP. Now you know why there are very few new products approved in Asia. These groups need to be overhauled if Bausch has any hope of ever being competitive with the big boys.
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The we are a development organization first and research organization second argument is a joke when you see submissions fail. D+R is focused on publishing articles, and obtaining patents for their resumes not getting products approved for sale. In each department you will have 9 guys working on activities that support their resumes and then there is one person that gets dumped on to help the project managers with their submission packages.

Unless you truly get more than one person to help out on submission packages then you can forget quality work in the submission packages. The VPs do the absolute minimum required to look like they are working on them and the rest of their department is set up to write up articles, patents and help the VP pump up their resumes as well.
 






No one was watching the store. The R+D VPs talked like they were focused on product approvals while in reality they were using B+L money for publications and resume building.

The price B+L will pay for trusting these charlatans will be a very low IPO value or bankruptcy.
 






"The quality and strength of the submission package is highly dependent on the quality of the the work from ROC R&D and Medical / Clinical Affairs."

If you did a complete review of this process you would find that the resources dedicated to this activity is really minimal. VPs put little of their own effort into this and the number of people that have this activity on their objectives is only a few people in each functional area.

This will not change. VPs are just bored stiff when these projects come their way. They will try to pawn it off and give the activities the least amount of resources as possible.
 






The way these submission packages work is that one person in the department does all the work. The VP and others in the department do as minimum as possible just enough to get credit if the package is approved. If the submission package is approved everyone then shares in getting equal credit for the approval. If the submission package fails everyone including the VP denies that they had much to do with the submission and make sure the one person that worked his ass off on the package gets all of the blame for the failure.
 






Don't worry about the submissions. The company will be sold by the end of the year and new executive management will be put in place. Just tell the new management that the old management never allocated enough resources for this activity and that is why the submissions are slow, of poor quality, and minimally address the concerns of the regulatory agencies these packages were submitted to.
 












Each department should have more than just a few people dedicated to this task. Also it should be a large portion of the VP/Director, Team members objectives for the year.

Also if a submission is rejected by a regulatory body the VP/Director should receive a low ranking for the year and a zero bonus.
 






Anonymous said:
Not an excuse. All of the people that need to give the project managers reports for these projects need to speed things up. Management will worry about the resource allocation in regulatory to make this happen.
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Surgical RA has been at 50% for about a year now. It recently lost its entire "International RA group," and projects are currently being worked on by college interns. ... and you say management cares about resource allocation?
 












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