Clinical Supplies Group Conference – Study Drug Returns and Reconciliation

A couple of weeks ago I attended and exhibited at the Global Clinical Supplies Group conference which was held at the wonderful Hyatt Regency Tamaya Resort & Spa in Santa Ana Pueblo NM .
Hyatt Tamaya resort & spa
It was a great meeting with about 250 attendees who specialize in the co-ordination of clinical study supplies and thirty something exhibitors.  The meeting was very well organized by George Wills and his colleagues on the GCSG committee with Steve Jacobs taking a lead as an enthusiastic master of ceremonies.
The meeting was a mixture of presentations and workshops all of which were well attended, it was great to see lots of participation in the workshops.
The presentations covered a wide range of subjects ranging from the utility of ISO as a support for GMP and GCP systems, an overview of the roles and responsibilities of an EU QP, a comprehensive review of the regulations pertaining to the importation of IMPs into each of the “BRICKS” countries and, as a finale, an excellent presentation (by a lawyer who specializes in working with the FDA) explaining how to handle inspection findings (with some excellent examples of what not to do).
As I have mentioned the workshops were well attended and mostly very “interactive.”  The great thing about workshops is that the subjects get developed in the discussion and I find I often walk away with new perspectives.

Temperature excursions

The highlight of the workshop on handling IMP temperature excursions was the revelation that having carefully packed a temperature monitor with the shipment all companies seem to have issues with study sites discarding them (and I thought it was just Velesco’s misfortune).

Veterinary medicine

As Velesco gets involved in veterinary product development I was enlightened at the investigational devices workshop that medical devices (including implants) for veterinary use are regulated by USDA – good to know.

Counterfeit drugs in clinical trials

I knew that counterfeit and adulterated drug products are a growing concern but wasn’t aware that they had surfaced in clinical studies.  This issue was addressed at the workshop on comparator sourcing where the subject of drug product pedigrees was explained and discussed.

Trial unblinding on social media

Unblinding a study via Facebook seems an unlikely scenario but it appears that the use of social media by clinical study participants is becoming a concern.  Reflecting on this it is kind of obvious that study subjects would share their experiences and if one person figures out how to tell active from placebo from comparator and publishes this……..

Clinical study returns

The final workshop attended was that on clinical study returns, accountability and destruction.  A lot of discussion on who reconciles to what level of accountability.  It appeared that most companies have the dosage form level accountability carried out at the study sites with subsequent reconciliation limited to the number of tamper -evident sealed containers received and packing lists (unless a controlled substance is involved).
A great meeting and I look forward to next year’s conference in Savannah, Georgia.

 

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