Helmut
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Vienna, Austria,
2019-07-02 11:05

Posting: # 20368
Views: 1,302
 

 European Bioanalysis Forum: ICH M10 Workshop [Bioanalytics]

Dear all,

presentations of the European Bioanalysis Forum’s Focus Workshop

ICH M10 – Public consultation & Industry Feedback
Towards a Science based Global Bioanalytical Guideline
(Barcelona, 20–22 May, 2019)

are [image] open access.

Cheers,
Helmut Schütz
[image]

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Science Quotes
wienui
★    

Germany, Oman,
2019-07-03 11:57
(edited by wienui on 2019-07-03 12:12)

@ Helmut
Posting: # 20370
Views: 1,198
 

 Helmut, you are the best

» presentations of the European Bioanalysis Forum’s Focus Workshop

ICH M10 – Public consultation & Industry Feedback
» Towards a Science based Global Bioanalytical Guideline
» (Barcelona, 20–22 May, 2019)

are [image] open access.

Dear Helmut,

As a truly member for this forum since some years, I would like to thank you very much for your continous efforts and all what you are doing at the highest level of professionality to facilate and promote the understanding the Bioequivalence study's for all of us regardless where we are from industry, regulatory bodies, CRO or acadima.

Thank you, Really you are the best.

wish you all the best,
Osama
Helmut
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Vienna, Austria,
2019-07-03 22:21

@ wienui
Posting: # 20371
Views: 1,158
 

 OT: A rant about the USP – a “non-profit” organization

Hi Osama,

» […] Thank you, Really you are the best.

THX – at least I try. :-D

For agencies and the academia I give lectures for free (OK, if they offer something, I don’t refuse). Of course, travel expenses have to be covered. However, I charge for the preparation. Ranges from practically nothing to a couple of days.

Sometimes strange things happen…
On short notice (end of April) I was invited by the USP/PQM to give a three-day workshop in Bangla­desh (see there). Incredible amount of paperwork from the USP. First they wanted a list of all my clients of the last three years together with my fees. I refused. Then at least three non-European “individuals that USP may contact for a reference”. Wow! Obviously my CV didn’t sufficiently demonstrate my professionalism.

[image]Workshop scheduled for June 25–27, clock ticking. After a lot of to and fro (82 e-mails), I had a contract covering three days of preparation. For the governmental visa I required:
  1. A return ticket.
  2. A person in Bangladesh “to act as guarantor”. Whatever that means.
  3. An invitation letter of the ministry.
Since there are just five air connections Vienna / Dhaka per week and only a few seats were left, on June 5th, I bought the ticket from my pocket. On June 6th, I e-mailed USP Bangladesh asking for the invitation. Reply: “Would you please let me know, from where you are going to apply for visa. I have to mentioned the address of Bangladesh Embassy.” OK, everyone involved in USP knew that I’m located in Vienna. Google would have helped.
E-mailed the address and 13 minutes (‼) later received the invitation from the “Government of the People’s Republic of Bangladesh, Directorate General of Drug Admi­nistration (DGDA)”. To the address exactly as I provided it. One single spaced page, extremely polite, describing that the DGDA is a sub-unit of the Ministry of Health & Family Welfare, what it does, purpose of my visit, my passport № and expiry date, name and address of hotel, stamped & signed in English and Bengali. According to the document information of the PDF it was scanned 9 minutes after my request… Great, fast typists. Wait a minute: Dated 26/5/2019 – which was eleven days before I requested it. Time machine? OK, not familiar with ALCOA. Expected eyes wide open at my lecture about GCP.

While I was enduring the visa-procedures (three visits1 to the embassy) the US-office of USP started to lament about the costs: “USP is a non-profit organization, limited budget, :blahblah: Everybody knows that the USP’s reference standards are more precious than gold… What are they doing with all the money? Also they added one item to the contract:
  • Review BE study report of recent Praziquantel BE study completed and prepare a small (3–4 pages) brief of variability of Praziquantel and how best to address it.
I refused. Told them that unless the report is completely screwed up (which takes me minutes to find out), I would need the raw data to re-calculate the study, etc. My software is installed/validated only on my workstation (which I rather prefer not to carry with me to Dhaka). Once I have the data in my office, I can give a cost estimate. Might take a few hours up to one week. Nevertheless, I like to support developing countries and gave them a discount (two days instead of three). Actually it took me almost 100 hours to get the stuff ready.

The day before the scheduled travel I e-mailed the hotel asking for a :smoke:-room, only to learn that the reservation was cancelled two weeks before.2 What the heck‽ E-mail to USP Dhaka. New reservation, other – better – hotel. Packed my bags, made a reservation for a taxi to the airport. The next morning after breakfast I switched my mobile on.3 Missed ten calls starting 5 a.m. and a couple of text-messages [URGENT!] Request to Hold your Travel for One week in Bangla­desh” and an e-mail “We are working on your contract – it is nearly ready. […] We would like to postpone by one week. We cannot have you travel until the contract is in place, and that is taking longer than anticipated.”

Splendid. Called them. Told them that:
  1. I really don’t give a shit whether the contract is signed or not. In three hours I will be airborn and ready to give the workshop the day after. If they won’t pay me, I’ll sue them. Easy.
  2. I can’t postpone sumfink “by one week” (no-show, ticket not endorsable). The governmental visa has a fixed date of entry; new ticket, another invitation letter of the Ministry, new visa application. Flying from Vienna to Dhaka is not like to Frankfurt. Five comfortable connections / week instead of twenty / day. Likely everything booked out already. OK, traveling first class would be an option. I’ve heard that the Emirates’ is nice. Reminded them that I payed the ticket myself cause they were simply too slow in their procedures.
  3. I’ll have a busy schedule over the summer. Earliest possibility first week of September (originally they wanted the workshop already in April, since sooo incredibly urgent).
  4. Total costs will be much higher than what they “saved” by the discount.
Whatever I said, the answer was that the contract is not ready. Apologies? Nope. Plan B? Nope.
State of affairs as of today: The USP doesn’t reply to e-mails and voice messages. Loss: 1,300 bucks for the airfare and one week of work.


  1. Great people. Welcomed with a big smile and a warm handshake. Offered a cup of tea and reading matter. Apologies that the officer is having her lunch break. In other embassies ([image] [image] [image]) I was always treated like a criminal.
  2. Imagine what might have happened if I wouldn’t contacted the hotel: Arrive there, no reservation (though hotels in the middle of the monsoon-season wouldn’t be booked out), find a room, get the next morning to the offices of the DGDA, and then?
  3. I am not obliged to use my mobile phone at all.


Update end of July: Received a call from the senior director of USP/PQM. “I was not aware of this. Thanks for the explanation. We will sort it out.”

Update end of September: Deafening silence.

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
wienui
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Germany, Oman,
2019-07-04 06:43

@ Helmut
Posting: # 20372
Views: 1,098
 

 OT: A rant about the USP – a “non-profit” organization

» Sometimes strange things happen…
» On short notice (end of April) I was invited by the USP/PQM to give a three-day workshop in Bangladesh

Hi Helmut,

This is more than good enough for writing a movie story about the suffering of a scienist to attend a USP conference, no doubt you will get extremelly more than you spent (time & money) from the movie revenue.

THIS IS CATASTROPHIC.

Have a nice day,
Osama
Helmut
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Vienna, Austria,
2019-07-04 11:35

@ wienui
Posting: # 20373
Views: 1,046
 

 OT: The USP – a non-profit (?) “organization”

Hi Osama,

» THIS IS CATASTROPHIC.

When I told this story to a friend, he replied:
As for this funny USP business, I can’t really say I am surprised but their reaction, anymore. I believe the way that each employee sees it is: “Well, I followed the protocol. None can blame me. It’s not my business to save costs or excel at my services. Just follow the letter of the procedure and I am a model employee.”

Reminds me on Little Britain.

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
ElMaestro
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Belgium?,
2019-07-04 12:05
(edited by ElMaestro on 2019-07-04 12:24)

@ Helmut
Posting: # 20374
Views: 1,032
 

 OT: A rant about the USP – a “non-profit” organization

I agree this is a catastrophic example of very bad planning.

In perspective:
I heard of a consultant somewhere who was asked to do a lot of work by a world-wide reputed organization and when he sent an invoice he was given the finger and told that consultants generally were free to say yes or no to work or to task orders, so if no task order was offered then he should not expect that the request for work would be accompanied by one and hence all work he would decide to undertake would be a case of volunteering. Apparently noone in said organization thought it inappropirate to ask for work from consultants without the ability to issue a task order.
The consultant had to write this off as a loss and learned a tough lesson: Reputed organizations can and will ask for work they can not or will not pay for and they will be happy to royally screw anyone dumb enough to proceed with delivery of work in good faith with the expectation of compensation.

I will not, of course, in any way insinuate or suggest or hint, that the world-wide reputed organization alluded to above is, or is affiliated with or identifiable as, USP and/or PQM.


Re. the actual case you are in, Hötzi:
My suggestion is to make known to USAID what is going on with the tax payer money, especially if you are now without a task order and out of pocket in good faith.
USP can easily hide behind the nonprofit excuses: The profits at USP technically have little to do with the resources received from the USAID grant which is what PQM use for the activities undertaken by consultants. The nonprofit aspect is irrelevant. What isn't irrelevant is if you are being screwed ten times over by them while they are spending US taxpayer money to haul in fat salaries and in the process creating very little activity for the grant.

I could be wrong, but...
Best regards,
ElMaestro
Helmut
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Vienna, Austria,
2019-07-04 12:47

@ ElMaestro
Posting: # 20375
Views: 1,019
 

 OT: Naïveté

Hi ElMaestro,

» […] Reputed organizations […] will be happy to royally screw anyone dumb enough to proceed with delivery of work in good faith with the expectation of compensation.

Delivered presentations (PPT/PDF) as well as handouts for BW-printing on June 21st. How stupid!

» My suggestion is to make known to USAID what is going on with the tax payer money, especially if you are now without a task order and out of pocket in good faith.

THX, I’m seriously considering it.

Reply of another friend:
I hate America anyway… I did a workshop for ██████ two years ago. They were supposed to pay the fare—then a week before they suddenly announced that there was a consultancy policy that consultants pay their own fares and hotel and claim back. I told them to forget it and then they sent me an advance on my fee to cover the flight. The rest took months to sort out, including the fact that they witheld tax even though I had filled in all the appropriate forms… Finally I was still left with an outstanding debt of around $ 2,000.
It’s like no one in the US has the faintest idea of the fact that things outside can be organised simply and properly. I have given up on the US.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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nobody
nothing

2019-07-04 14:14

@ Helmut
Posting: # 20376
Views: 1,001
 

 OT: Naïveté

...they need it for the wall. And the tanks... Sorry for mildly OT post :-D

Kindest regards, nobody
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