Re: [NMusers] FDA commissioner's blog on Modeling and Simulation

[Kimko, Holly [JRDUS]]

Hi

I wonder when the other variables (DVID>1) will be available. I see that IRP 
had been included but cannot find Nab (neutralizing antibody). May I have that 
variable values?

Best,
Holly

On Jul 29, 2017, at 4:27 PM, Wang, Yaning 
> wrote:

Dear Colleagues:

We should feel proud of what we do. Please see the encouraging blog from the 
FDA commissioner, Dr. Scott Gottlieb.

https://blogs.fda.gov/fdavoice/index.php/2017/07/how-fda-plans-to-help-consumers-capitalize-on-advances-in-science/


Yaning Wang, Ph.D.
Acting Director
Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: 301-796-1624
Email: yaning.w...@fda.hhs.gov
Disclaimer: The contents of this message are mine personally and do not 
necessarily reflect any position of the Government or the Food and Drug 
Administration.

[NMusers] 2nd European Training Course on PK-PD of Protein Therapeutics, Darmstadt, August 29-31 2017: few seats available!

[Emilie Henin]

Dear Colleagues,



Few seats are still available for the

*2nd European Training Course on Pharmacokinetics and Pharmacodynamics of
Protein Therapeutics – Principles and Pharmacometric Approaches*



Directed by Bernd Meibohm (University of Tennessee) and Johan Gabrielsson
(Swedish University of Agricultural Sciences )

To be held in Darmstadt, Germany on *August 29-31, 2017*.



Thanks to the sponsoring of Merck,  seats for academics and students are
available at a reduced fee (500€ instead of 1400€, including fees for
course, lunches and coffee breaks)





For more information, please contact us at cont...@ap2pop.org or click on
the links below



*Information:* *http://www.ap2pop.org/formations
*

*Registration form:*
http://www.ap2pop.org/assets/PDF/Plaquette-formation-AP2POP-2017-PKPDofPT.pdf






On behalf of the organising committee,





*Emilie HENIN, PhD HDR*

Consultant in Pharmacometrics



AP2POP, Association pour la Promotion de la Pharmacocinétique de Population

Secretary of AP2POP



2017-05-11 17:56 GMT+02:00 Emilie Henin :

> Dear Colleagues,
>
> We are happy to announce the
>
>
>
> *2nd European Training Course on*
> *Pharmacokinetics and Pharmacodynamics of Protein Therapeutics –
> Principles and Pharmacometric Approaches *
> that will be held in Darmstadt, Germany on August 29-31, 2017.
>
> The 3-day course is a shortened version of the course which has been given
> for the last seven years  by Prof Bernd Meibohm & Johan Gabrielsson in the
> United States, and it is organized in EUROPE under the aegis of AP2POP and
> with the sponsoring of Merck.
>
>
>
> During this course, you will be introduced to basic principles in the
> pharmacokinetic and pharmacodynamic evaluation of novel therapeutic
> proteins and hands-on exercises in the PK/PD evaluation of these compounds.
> Topics include target-mediated drug disposition, tissue and tumor
> penetration, first-in-human dose selection, immunogenicity, clinical
> pharmacology challenges, biosimilars, and drug-drug interactions. The
> target audience comprises pharmaceutical scientists from industry, academia
> and regulatory agencies with basic knowledge in PK and PKPD that would like
> to receive a comprehensive overview or refresher on the PK and PKPD of this
> class of compounds. Hands-on exercises will be performed individually and
> in small groups using simple software tools (no prior experience required).
>
>
>
> *Attendance and registration:*
>
> The attendance will be strictly limited to 35 participants, allowing nice
> interactions. As well, a limited number of spots have been reserved for
> academia and trainees for one third of the price thanks to Merck
> sponsoring.
>
>
>
> For more detailed information on the preliminary course program, as well
> as on the registration process, please visit:
>
> *Information:*   http://www.ap2pop.org/formations
> 
>
> *Registration form:* http://www.ap2pop.org/assets/PDF/Plaquette-formation-
> AP2POP-2017-PKPDofPT.pdf
>
>
>
>
> Looking forward to seeing you in Darmstadt next summer !
>
>
> *The Course Directors*
> Bernd Meibohm, University of Tennessee & Johan Gabrielsson, Swedish
> University of Agricultural Sciences
>
>
>
> *The Local Organizers*
>
> Pascal Girard and Maike Puetter, Merck; Christian Laveille, Calvagone
>

Recall: [NMusers] FDA commissioner's blog on Modeling and Simulation

[Kimko, Holly [JRDUS]]

Kimko, Holly [JRDUS] would like to recall the message, "[EXTERNAL]  [NMusers] 
FDA commissioner's blog on Modeling and Simulation".