Overview
With regulatory inspectors increasingly finding issues with vendor oversight by sponsor
organisations, it is becoming even more important for the pharmaceutical industry to
employ efficient and accurate strategies for managing outsourced activities. A company’s
ability to identify and select the right CRO/ vendor for the right project and manage them
efficientlyandeffectivelywillhelptoensurecompliancewiththeregulator’sexpectations.
On this course you will learn how to prepare a request for proposal (RFP), evaluate and
select the right CRO and establish procedures for vendor oversight for projects you
need to outsource. You will also cover the techniques for successfully managing CROs/
vendors and the shared responsibilities required by the sponsor and the service provider.
Managing Vendor performance issues will also be discussed.
The course is equally useful to CROs/other vendors and consultants to understand how
to work effectively with sponsor organisations.
Who should attend?
This course is designed for personnel involved in CRO/vendor oversight in the
pharmaceutical, biotechnology, animal health and medical device industries including
those working in clinical research, regulatory affairs, pharmacovigilance, manufacturing,
clinical outsourcing, contracts, quality, clinical operations, vendor management and
global QA/compliance. It will also be relevant for outsourcing, purchasing, finance and
contract management staff who participate in the RFP process who will find this course a
valuable introduction or refresher course focusing on best practice.
This course will also help CRO/vendor personnel to work more successfully with
pharmaceutical, biotechnology and medical device companies through gaining a much
clearer understanding of their needs when outsourcing.
Trainer
Key Topics
Learning Outcomes
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FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up