Sandra,
Your post turned me on today.
To my experience, it is not uncommon to see such a client even in the US. I can share many cases that may/can blow your mind.
To make a long story short, I believe any consultant should have his/her bottom line (ethics, integrity and philosophy) including what/how/when/where you can draw a line.
Here are types of clients.
Type A (Ace): willing to pay for what you ask for-no problem.
Type B (mind-Boggling) -willing to pay for what you ask for but they may/can drain your emotion - some problems.
Type C (Cra***) - willing to argue or dispute for every penny, min and/or hour! - lots of problems
Type D (Defensive) - willing to pay for what's agreed for, but so darn defensive for some scientific/technical issues even when no brain is actually needed to figure out the issues- lots of problems.
I can handle All Types (A through D).
Some consultants may take only A. For you, which types would you be ready, willing and able to work with?
Industry professionals should be aware of the US Supreme Court Case in 1975 at
http://wp.me/P4xpOK-Kd, which is applicable for an individual in a company.
Thus, it is highly recommended/suggested that we exercise our discretion within the boundary of applicable laws in a reasonable, justifiable manner!
It is up to you whether you want to go beyond the limit of your own guidelines.
If you ask me a point blank, I would most likely suggest you'd better recuse yourself from the project. But for me to make definite suggestions, I would need to know more about your client and the technical/scientific/regulatory issues as well.
David
Original Message:
Sent: 02-01-2015 09:47
From: Sandra Hecker
Subject: Great Chapter event with DC/MD/VA chapter-shall we do it again?
Thanks David and those of you who contacted me privately via Linked In. I just mean I'd love it if we could, using the RAPS mailing list, contact all local RAPS members, to set up happy hours (I'd organize one!) on particular days/times at specific places. WHOEVER could attend, would, and we'd see what issues people have, discuss them. I would not expect to charge for my advice at such a happy hour, or be charged. We'd have informal, discussions that yes, possibly offline, later, COULD lead to hiring someone for a project, but that is not my main intent here. Probably all of us consultants have our extensive contact/collaborator lists for expertise a project may need, but we don't have personally--in my case, all kinds of CMC or non-clinical experts hired as needed for a project. But right now, I have a foreign client with all sorts of issues including their refusal to understand what FDA has told them prior to me getting involved (I've read the FDA minutes, told them many times they did not meet FDA requirements previously--they deny this) and total lack of understanding of GCP--it's unbelievable! Definitely brainstorming with other RA experts, and I mean experts, would be helpful. I'd see if anyone has dealt with these specific issues (discussed over beer or wine!) or this sort of client before, successfully? How? (or should I just resign from trying to help the client, as I'm tempted to do!) I will not file inappropriate submissions to FDA.
-------------------------------------------
Sandra Hecker RAC
President
Hecker & Associates LLC
Arlington VA
United States
-------------------------------------------
Original Message:
Sent: 01-31-2015 13:12
From: David Lim
Subject: Great Chapter event with DC/MD/VA chapter-shall we do it again?
Sandra,
Whenever you need someone to mutually brainstorm your regulatory issues even through a phone or email, you may contact me - I can be almost equally lively through a phone or an email to an in-person discussion.
____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Original Message:
Sent: 01-31-2015 12:51
From: Sandra Hecker
Subject: Great Chapter event with DC/MD/VA chapter-shall we do it again?
We're lucky to be local to FDA, so I greatly value talking with FDA staff offline at RAPS events. I too work in VA, and for many of us, clients must come first--if there's a deadline or crisis, I have to keep working. I find the RAPS local events too early, too far away, and too expensive considering what they provide. I suggest periodic happy hours in DC or Arlington, to which all RAPS members are invited, for free. Each person who can attend, doesn't have to pay ahead, and can buy what he or she wants at the venue--I don't want free appetizers or "how to handle office discussions" programs--I want to brainstorm with other working RA experts, about my most recent RA issues/questions. Someone else in this thread noted other meet up events are free, unless there's a great speaker or an elaborate program. Some of my local RA friends and I are tired of having to miss RAPS events (or be charged much more, unexpectedly, at the door, if we realize last minute we can make an event, and given the distance/time to Gaithersburg, during rush hour, are slightly late). In the last few years, RAPS has become extremely mercenary, charging for everything. For those of us who are not RA novices, paying $15 to simply be at the same place at the same time as other RAPS members for free appetizers and a planned discussion not of interest to us, is not worth the cost, and in fact is annoying--I'd rather buy a colleague a drink for the $15 and brainstorm about our issues.
-------------------------------------------
Sandra Hecker RAC
President
Hecker & Associates LLC
Arlington VA
United States
-------------------------------------------
Original Message:
Sent: 01-30-2015 15:07
From: Maxwell Stinehour
Subject: Great Chapter event with DC/MD/VA chapter-shall we do it again?
I would gauge my interest as MODERATE. Traveling that far north on a week night is challenging, so any opportunity for a Richmond or Virginia Beach area meeting would be welcomed!
-------------------------------------------
Maxwell Stinehour
Richmond VA
United States
-------------------------------------------
Original Message:
Sent: 01-26-2015 10:46
From: Andrea Chamblee
Subject: Great Chapter event with DC/MD/VA chapter-shall we do it again?
A few members reported that they wanted more events like the Happy Hour we had at the Baltimore Washington chapter January 22. Nancy Singer did a great job and we got a chance to meet and talk over snacks and drinks. My table discussed starting a Meet Up group to do it more often, but before I invest in that, I thought I would explore getting together on this discussion board. RAPS has some great events planned for the coming months, and I don't want to dilute their impact. However, if people want to get together in between let me know your level of interest. The get togethers can have a theme, an attendee limit like a small dinner, or be wide open.
Our chapter tends to have a lot of people who get stuck at the office, and winter weather is pretty unpredictable. Please consider that when you decide your level of interest. Is your interest really high enough to not be a No-Show? The advantage of Meet Up is we can track no-shows, charge dues, and collect fees to cover MeetUp costs; but it is more work for organizers.
If you are in the DC/MD/VA area, please respond to this message and indicate whether your interest is HIGH (no way would you ever be a no-show!); MODERATE (you'll do your best and come when you can); or NONE (there are already enough meetings). Thanks!
-------------------------------------------
Andrea Chamblee RAC, FRAPS
FDA
Silver Spring MD
United States
-------------------------------------------