About the conference

The two-day conference was entirely dedicated to bringing together the latest advances, challenges and opportunities for developing medicinal products and medicinal devices for paediatric use from EU and US perspective. Specifically aimed at providing exposure to emerging practical applications and illustrate specific remedies utilized by paediatric drug development teams to overcome hurdles faced in developing medicines for 0-17 years old.

An exciting programme was organised to focus on three themes:

• state of the art plenary presentations [such as update on EMA guidelines on Pharmaceutical Development of Medicines for Paediatric Use, achievements of the WHO ‘Make Medicines Child Size’ programme, PK & bridging studies in paediatric drug development, AAPS white paper and FDA views,
• thematic sessions covering the five work streams of EuPFI including the launch of STEP database, and
• case studies, emerging technologies & research through soap box sessions and posters.

Selected Poster were presentations on the conference topics (instructions on EuPFI website).

This conference offered an excellent and time-effective way of gaining updates on key themes, as well as interacting with colleagues from across  industrial, regulatory, academic and clinical professions.

We invite you to note the dates of 5^th EuPFI conference in your diary and begin planning your participation, as well as your abstract submissions.

Conference Proceedings

Plenary Presentations  

Hosting Institution

European Paediatric Formulation Initiative in partnership with International Association for Pharmaceutical Technology.

Conference Venue

Congress Center: Institute of Molecular Genetics of the ASCR, v.v.i. (IMG), Vídeňská 1083, 142 20 Prague 4, Czech Republic

Important Dates

July 15th, 2012	Second announcement
March 5th, 2012	On-line registration and abstract submission open
June 1st, 2012	Abstract submission deadline EXTENDED to 15th June 2012
July 1st, 2012	Notification about abstract acceptance (preliminary date)

Conference Dates

September 19^st to 20^th, 2012

Preliminary programe is available for download in PDF format below.

4th EuPFI Conference - Preliminary Program

Call for Abstracts & Submission Guidelines

The abstract submission is closed. Thank you very much for your contribution

Instructions for Poster and Oral Presenters

Oral Presentation

Oral presentations (except plenary and keynote) have a 12 minutes slot – please prepare a PowerPoint presentation that lasts for up to 10 minutes MAXIMUM to allow 2 minutes for discussion after your talk. This equates to roughly 10 slides including your title and acknowledgement slides.




Please make sure you finish your talk with in 10 minutes - it is a good idea to rehearse it beforehand to check your timings- to allow plenty of time for discussion from the audience. We will give you a warning at 9 minutes so you have a minute to wrap up. We will be very strict about timing and will stop you when your 10 minutes is up even if you have not finished. If you need any further information please do not hesitate to get in touch.

Power Point presentation of all speakers must be delivered to the resigistration desk on the first day of the conference, alternatively you can send the presentation to s.salunke@ucl.ac.uk. Conference organisers will be available to help you download and run-through.

Final program with the time and date of presentations will be posted on the congress web site by September 10th.

Poster Presentation - click here

Registration Guidelines

All participants are kindly recommended to register via Online Registration Form on APV website. Please read the instructions on the APV website carefully.

To benefit from the reduced early registration fee, please process your registration before July 15^th, 2012.

Upon submitting the Registration Form, You will receive a confirmation by e-mail of your registration with the invoice.

All participants are kindly requested to register in advance by completing and submitting the Registration Form with the appropriate fees.

Registration fees

Please note unpaid pre-registration will not be considered as a valid registration unless fully paid and confirmed. Pre-registration summary therefore cannot be taken as a valid registration confirmation. Please make sure to pay your registration fee within the time frame for early or regular registration.

Registration fee	Early bird	Full Fee
	by July 15th
Non-Member (Non Academic, Non Governmental)	1075 €	1175 €
Member of APV (Non Academic, Non Governmental)	945 €	1045 €
Non-Member (Academic, Governmental)	425 €	475 €
Member of APV (Academic, Governmental)	360 €	410 €
Students (please enclose evidence*)	195 €	225 €

 
Registration fees are stated including 20% VAT.
 

* Students have to submit a copy of their student ID to the Conference email/contact address or fax number. Please note that if we do not receive this certification within 7 days after your data submission your registration will not be considered as valid. 

Delegate registration fee includes

• Admission to scientific sessions, exhibition and poster area
• Conference materials
• Coffee breaks
• Lunches
• Conference Dinner & Social Programme

Insurance

The registration fees do not include insurance of participants against accidents, sickness, cancellation, theft, property damage or loss. Participants are advised to take out adequate personal insurance.

Confirmation

Upon receipt of the correct registration fee (clear of bank charges), each participant will receive a confirmation of registration. Please bring this confirmation to the Registration desk at the conference venue as proof of your registration. Confirmation will be sent upon receipt of payment.

Payment

All fees for the Conference registration should be paid in EUR (€), free of all bank charges.

Payment options

• credit card payment (Visa, Eurocard/Mastercard)
   
• by bank transfer
  

Cancellation / Refund Policy

We would like to point out that participation can be cancelled free of charge within two weeks of registration via the web.

Publication in the list of participants

In case you wish not to include your name and email address in the list of participants please send email to the Conference secretariat.

Responsibility

The participant acknowledges that he/she has no right to lodge damage claims against the organisers should the holding of the Conference be hindered or prevented by unexpected political or economic events or generally by force majeure, or should the non-appearance of speakers or other reasons necessitate programme changes. With registration, the participant accepts this proviso.

List of Hotels

  Participants should make their own hotel reservation referring to the APV seminar. Please use the form available on following link below for hotel bookings http://www.czech-in.org/eupfi/accommodation.aspx

Accommodation Information

List of Hotels

Hotel	Single Room	Double Room	Distance from the venue
Panorama Hotel Prague	107 EUR 116 EUR	118 EUR 127 EUR	18 mins by bus
Rezidence Emmy	56 EUR	70 EUR	10 mins walk

All rates are including 14%VAT, municipal taxes and breakfast.

ONLINE RESERVATION FORM 
Reservation conditions 
 
CONCERNING QUESTIONS, CHANGES OR CANCELLATIONS, PLEASE, CONTACT THE ACCOMMODATION AGENT:
 
CZECH-IN s.r.o.
Prague Congress Centre
5. kvetna 65
140 21 Prague 4
Czech Republic
Tel: +420 261 174 304
Fax: +420 261 174 307 
E-mail: eupfi2012.hotels@czech-in.cz

 

Hotel Description

Rezidence Emmy****

K Zelené louce 2a 140 00 Prag 4 - Krč |Phone: +420 246 020-004 |Fax: +42 246 020-155|E-mail: reservation@emmy.cz

The The Emmy Residence is a well-appointed four-star hotel located in a peaceful area of Prague 4 – Krč in the neighbourhood of Kunratice Forest and the Institute for Clinical and Experimental Medicine (IKEM). The hotel features cheap accommodation in Prague 4 with above-standard spacious rooms with free WiFi and free parking places right at the hotel.

Distance from the venue: 800m/10min, walking distance http://www.emmy.cz/en/

 

Panorama Hotel ****

Milevska 7, 14063 Prague,Czech Republic |Phone: +420 26116-1111 |Fax: +42 26116-4141 |E-mail: welcome@panoramahotelprague.com

Newly Ideally situated in a peaceful area just outside the city centre, the Panorama Hotel Prague is the perfect base from which to explore the city. It offers all the comforts and services of an international first class hotel, while being excellent value for money. With 450 king size double and twin rooms (mostly non-smoking), it is renowned for its deluxe American breakfast buffet, as well as the MEZZO restaurant, which offers mid-week business lunches and a-la-carte dinners. The casual Panorama Café is ideal for meeting friends or, for guests seeking some rest and relaxation, there is a wellness and fitness centre located on the top floor featuring a panoramic pool.

 

Distance from the venue: 7.5km/18mins – bus 193 to the Institute of Molecular Genetics of Academy of Sciences from station Sídliště Pankrác, located next to hotel http://www.panoramahotelprague.com/home?l=1

Free transportation for conference participants who reserved the room through the Accommodation Agent is provided.

Plenary presentations

Welcome and Introduction

Catherine Tuleu, PhD, Chair of EuPFI, UCL School of Pharmacy, London, United Kingdom

Prof. Jörg Breitkreutz, PhD, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

Comments on the EMA draft guideline: final steps towards a harmonized view between regulators and industry

Diana van Riet-Nales, PharmD, Co-ordinator, Section Chemical Pharmaceutical Assessment (CFB),

Medicines Evaluation Board (MEB), Bilthoven, The Netherlands

AAPS paediatric task force and its White Paper

Georgia Charkoftaki, PhD, University of Athens, School of Pharmacy, Laboratory of Biopharmaceutics

and Pharmacokinetics, Athens, Greece

Reflection on the achievements of the ‘Make Medicines Child Size’ programme: what next?'

Kris Weerasuriya, PhD, Medical Officer, Medicine Access and Rational Use (MAR), Essential Medicines and

Pharmaceutical Policies (EMP) World Health Organization (WHO), Geneva, Switzerland

Challenges and opportunities for developing pediatric products: A FDA Perspective

Mansoor A. Khan, R.Ph., PhD, Director of product quality research in the Center for Drug Evaluation

and Research at the US Food and Drug Administration, Silver Spring, United States

PK & bridging studies in pediatric drug development

Benedicte Ricci, PhD, F. Hoffmann-La Roche, Basel, Switzerland

Focus Sessions Presentations

Focus Session: Extemporaneous preparations

Chair: Jeff Rothwell, Rosemount Pharmaceuticals Ltd, Leeds, United kingdom

The MODRIC (manipulation of drugs required in children) study

Catrin Barker, Alder Hey Children's NHS Foundation Trust, Liverpool, and Cheshire Merseyside &

North Wales Medicines for Children Local Research Network, Liverpool, United Kingdom

What is extemporaneous and how to control it!

Terry Ernest, PhD, GlaxoSmithKline, Harlow, United Kingdom

Mixing medicines with foods and drinks - latest regulatory considerations

Caroline Le Barbier, PhD, EMA and FWG PDCO, London, United Kingdom

Focus Session: Excipients

Chair: Jörg Breitkreutz, PhD Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany

Safe drugs for neonates: the European Study of Neonatal Excipient Exposure (ESNEE) project

Mark Turner BSc, PhD, MBChB, MRCP(UK), MRCPCH, DRCOG, Department of Women's and

Children's Health, Institute of Translational Medicine and School of Reproductive & Developmental

Medicine University of Liverpool, Liverpool, United Kingdom

Launch of the STEP (Safety and Toxicity of Excipients for Paediatrics) database

Smita Salunke, EuPFI, London, United Kingdom

and

George P. Giacoia, MD, Eunice Kennedy Shriver NICHD, NIH, Bethesda, MD, United States

Focus Session: Administration Devices

Chair: Herbert Wachtel, PhD, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

EuPFI activities: Administration devices for children

Jenny Walsh, BPharm (Hons), PhD, MRPharmS Jenny Walsh Consulting Ltd, Nottingham, United

Kingdom

Needle free parenteral administration for children: current status and future trends, an

industry perspective

Anand Subramony, PhD, Principal fellow and Head, Novel Delivery Technology & Therapeutics, Novartis Institutes for Biomedical Research Inc., Cambridge, United States

Evidence Based Design Of Face Masks For Infants & Young Children

Israel Amirav, PhD, Pediatric Department, Sieff Hospital, Safed, Israel

Focus Session: Taste Masking and Taste Assessment

Chair: Catherine Tuleu, PhD, Chair of EuPFI, UCL School of Pharmacy, London, United Kingdom

Palatability assessment in children: Why? When? How?

Assoc. Prof. Mario G. Bianchetti, MD, Medical director at the integrated Department of Pediatrics,

Bellinzona-Mendrisio, and associate Professor at the University of Bern, Bellinzona, Switzerland

Potentiometric sensor array for the assessment of taste-masking of APIs

Prof. Wojciech Wroblewski, PhD, Warsaw University of Technology, Department of Microbioanalytics,

Warsaw, Poland

Focus Session: Age Appropriate Formulations

Chair: Sabine Desset-Brethes, PhD, Novartis Pharma, Basel, Switzerland

Microparticulates as drug carriers for paediatric use

Fréderic Gerber, PhD, Glatt, Binzen, Germany

Gastrointestinal models (TIM) with high predictive power, even for children?

Robert Havenaar, PhD, TNO, Zeist, The Netherlands