The next generation pharma skills you will need in view of continuous manufacturing 11-13 Oct, 2017, Ghent, Belgium

Het Pand Ghent

Fully booked - They have registered delegates: UCB, Fette Compacting, GSK, Arlenda, European Medicines Agency, US Pharmacopeial Convention, Federal Agency for Medicines and Health Products, Siemens, Bayer, Baxter, GEA, PSE, AstraZeneca, Johnson and Johnson, Galapagos, LEO Pharma, Pharmavize, PwC, MW Group, Bosch, Elscolab, Glatt, L. B. Bohle Maschinen + Verfahren GmbH, Ashland Industries, NNE, EMA, University College Cork, Ghent University, Free University of Brussels, University of Leuven, University of Limerick

Day 1 - Wednesday Oct 11th

Introduction to continuous manufacturing platforms and material characterisation

8.30-9.00amRegistration and coffee
9.00-9.30amWelcome and introduction
9.30-10.30amImportance of raw material and formulation blend characterization (raw materials and blends) - Jens Dondt (UGent)
  • Relevant raw material and blend properties and their characterisation techniques
  • Material property data bases: overview, predictive use and challenges
  • Excipient variability case – Prof. Thomas De Beer (UGent)
10.30-11.00amCoffee break
11.00am-12.00pmImpact of material properties on the behaviour, performance and residence time of screw feeding systems in a continuous manufacturing platform - Dr. Valérie Vanhoorne (UGent)
12.00pm-1.00pmLunch break
1.00-2.00pmStatus quo continuous manufacturing according to GEA - Joel Aerts, Jake Deighton (GEA)
2.00-2.45pmCase study: Design space determination of a continuous tablet manufacturing process via wet granulation through empirical process models - Prof. Thomas De Beer
2.45-3.15pmCoffee break
3.15-4.30pmEmpirical versus mechanistic modelling of continuous drug product manufacturing processes - Prof. Ingmar Nopens (UGent)
  • The fundamentals of mechanistic modelling
  • How do empirical and mechanistic modelling complement each other?
  • The importance of proper data collection
4.30-5.00pmTake home message of the day
7.00pmSocial event and dinner at a nice location in Medieval Ghent

Day 2 - Thursday Oct 12th

Modeling and simulation in view of continuous manufacturing towards design space determination

8.30-9.00amRegistration and coffee
9.00-9.15amIntroduction to Day 2 - Prof. Thomas De Beer (UGent)
9.15-9.45amCurrent status on feeding and blending modeling – Prof. Thomas De Beer (UGent)
9.45am-3.45pmmodeling of continuous manufacturing unit operations
9.45-10.15amtwin-screw granulation: collection of high quality data for model development, calibration and validation – Maxim Verstraeten (UGent)
10.15-10.45amCoffee break
10.45-11.45amTwin-screw granulation: model development, calibration and validation – Prof. Ingmar Nopens & Daan Van Hauwermeiren (UGent)
11.45am-12.45pmLunch break
12.45-1.45pmData collection and modeling of drying and milling in a continuous manufacturing platform – Prof. Ingmar Nopens and Michaël Ghijs (UGent)
1.45-2.30pmTablet process modeling and control – Wouter Grymonpré (UGent)
2.30-3.00pmCoffee break
3.00-4.00pm A holistic systems view of drug product manufacture and in-vitro / in-vivo performance - Flowsheet modelling – Dr. Sean Bermingham (PSE)
4.00-4.45pmOptimal experimental design (OED)
  • OED vs Design of Experiments (DoE)
  • OED for efficient model calibration and process optimisation for new formulations
  • Uncertainty analysis as essential step in the establishment of the model based Design Space determination for continuous manufacturing processes
4.45-5.15pmTake home messages of the day

Day 3 - Friday Oct 13th Different venue!

PAT for monitoring and control of continuous manufacturing processes

8.00-8.30amTransport to other venue
8.30-8.45amRegistration and coffee
8.45-9.00mIntroduction to Day 3 – Prof. Thomas De Beer (UGent)
9.00-9.30amPAT for monitoring and control of continuous manufacturing processes for drug products - Prof. Thomas De Beer
  • SPC
  • Traceability
  • F-test
9.30-10.30pmImportance of data management systems for continuous manufacturing processes – Jan Verelst (Siemens)
10.30-11.00amCoffee break
11.00am-12.00pmContinuous Manufacturing: EMA experience and regulatory considerations – Dr. Dolores Hernán (European Medicines Agency)
12.00-1.00pmLunch break
1.00-2.00pmAdvanced process control of continuous processes for drug products – Niels Nicolaï (UGent)
2.00-4.00pmParallel demos
  • PAT for process monitoring & control of continuous twin screw granulation
  • Implementation of in-line PAT tools on a rotary tablet press: API quantification, RTD and punch monitoring (CDAAS)
4.00-4.30pmAdvanced modelling for process optimisation and design - AM-TEAM
4.30-4.45pmEvent wrap-up

Speakers

Academic, industry and regulatory experts

  • Dr. Dolores Hernán (European Medicines Agency)
  • Ir. Jan Verelst (Siemens)
  • Dr. Sean Bermingham (PSE)
  • Prof. Thomas De Beer (Ghent University)
  • Prof. Chris Vervaet (Ghent University)
  • Prof. Ingmar Nopens (Ghent University)
  • Joel Aerts and Jake Deighton (GEA)
  • Multiple scientists with hands-on expertise

13th century building 'Het Pand', Ghent, Belgium

The venue ‘Het Pand’ is a former Dominican monastery which is located in the historical centre of the city, on the banks of the river Leie. The oldest parts of this impressive building date from the 13th century. During five centuries it was extended and refashioned in different styles. ‘Het Pand’ houses some valuable collections, such as the rich ethnographical and archaeological collections of the University, the Museum for the History of Medicine, full-size photographs of paintings of Bruegel and Early Dutch Masters, and an interesting collection of stained glass. Het Pand is located at Onderbergen, 1, in the immediate vicinity of ‘Sint-Michiels’- Church

Het Pand

Hotel suggestion:

Sponsoring and exhibition

We offer the opportunity to become a sponsor and exhibit on Oct 11th and 12th (on Oct 13th, we move to another location). Booths will be located in the coffee break and lunch area. Complete information can be found in the sponsors guide. Contact us for sponsoring and exhibition opportunities at training@AM-TEAM.com.

Kloostergang Het Pand

Exhibitors:

Siemens, Glatt, Elscolab

Demo's and hands-on activities are organised entirely by UGent and will include:

  • Impact of material properties on the behaviour, performance and residence time of continuous manufacturing unit operations
  • PAT for process monitoring & control of a continuous manufacturing process based on twin-screw wet granulation (ConsiGma25)
  • Population balance modelling of twin-screw granulation (particle size and property modelling)

Organised by:

BIOMATH, LPPAT, UGent, AM-TEAM

Claim your spot (fully booked)

Online payment is not possible. We will send you an invoice after registration.

Rates EUR, excl. VAT

  • Industry: 1,900
  • Government/academia: 1,200
  • Students: 1,000
Pharma training course

Your registration implies that you agreed to pay regardless of your attendance. Cancellations will be assessed a non-reimbursable fee of 800 EUR per attendee. Cancellations made after August 11th, 2017 will not be reimbursable and will require full payment. The organisers have the right to modify the program.

Please direct purchase orders to:

AM-TEAM BVBA
Hulstbaan 63, 9112 Sint-Niklaas, Belgium
VAT: BE0669.934.062

Questions?

training@AM-TEAM.com