The conference will be held at the Basel University Children's Hospital. The address is Spitalstrasse 33, Basel.

Basel

Basel is the third largest city in Switzerland and is located in the Northeast of the country, on the border of France and Germany. It is an important economic center in Switzerland and offers a rich cultural life. It is home to the Museum of Fine Arts, which holds the most significant and largest collection of art in Switzerland, the Foundation Beyeler, the Theater Basel and the Musical Theater Basel.

Located on the bank of the Rhine and situated only a few kilometers from the German Black Forest and French Vosges, it also offers great possibilities for excursions in the nature.

University of Basel

The University of Basel was founded in 1460 and is the oldest university in Switzerland. It prides itself in its tradition of over five hundred years of excellence in teaching, learning, and research, during which it has adopted a forward-looking approach to new developments in science to provide high-quality education and underpin its well-deserved reputation as a university capable of attracting staff and students from all over the world. Located in the heart of Basel, and drawing on innovation anchored in tradition, the University of Basel is dynamic and innovative. Research at the University of Basel focuses on the life sciences and culture. Both core areas comprise a wide range of projects, involving research staff and scientists committed to interdisciplinary work and a cross-faculty approach to advancing the knowledge of life and the workings of culture. The University of Basel is committed to providing state-of-the-art education and to facilitating outstanding research. (Adapted from www.topuniversities.com).

How do I get to the venue? 

Staying in Basel

Commercial Drug Development MasterClass

Wednesday, 1^st February 2017, Basel, UKBB

Trainer:  Martin Austin, Basel, Switzerland

8:30h	Registration & Coffee
9:00h	Welcome
9:10h	"Over the Rainbow" - Making medicines from ideas
9:50h	Steps to successful commercialization: An Overview
10:30h	Morning coffee
11:00h	Step 1: know yourself! Could you pull it through?
11:30h	Step 2: Environment, Market & Competition
12:00h	Step 3: Creating a Plan : The threshold criteria.
12:30h	Wrap-Up
13:00h	End of Masterclass

Pediatric Drug Development MasterClass

Wednesday, 1^st February 2017, Basel, UKBB

Trainer: Klaus Rose, klausrose Consulting, Basel, Switzerland

13.30h	Registration & Coffee
14:00h	Welcome
14:10h	EU & US Pediatric pharmaceutical legislation
14:40h	The EU Pediatric Investigation Plan (PIP)
15:30h	Childrens’ special needs in pharmaceutical treatment:  developmental physiology, pediatric formulations, pediatric  clinical pharmacology
16:00h	Operational challenges of pediatric clinical trials: Protocol & study design Center selection, patient screening, recruitment Remuneration for parents & patients Patient retention Monitoring
16:30h	Break
17:00h	Impact of US & EU pediatric legislation on drug  development
17:30h	Interactive training : EMA pediatric website
18:00h	Wrap-Up & End of Masterclass

Publication Opportunities

Special issue related to this conference in the journal Children.
Children (ISSN 2227-9067) is an international open access journal of pediatrics published quarterly online by MDPI. The publication focuses on sharing clinical, epidemiological, translational and basic science research relevant to children’s health.

Special Issue Information

Dear Colleagues,

The value of licensed and appropriately labeled medicines for children and adults is increasingly a focus of public awareness. This is, for a large part, the result of US and EU legislation on paediatric and orphan diseases. However, paediatric clinical practice has changed less than expected, and the initial enthusiasm has been replaced by a more realistic assessment. Breakthrough therapeutic innovations have been introduced in the last decades, e.g. for cystic fibrosis, metabolic diseases or hormonal defects. However, none of these were triggered by paediatric legislation. The aim of this special issue is to provide an update on both state-of-the-art methodology and operational challenges in research & development of paediatric and rare diseases, in order to re-evaluate what is needed for more progress in the development of treatments for both paediatric and rare diseases.

We welcome original research, review, opinion papers, editorials, or short communications on the following topics: paediatric legislation, commercial drug development, development of orphan and paediatric drugs, paediatric clinical research, developmental pharmacology, neonatal pharmacology, paediatric pharmacology, neonatal medicine, neonatal infectious diseases, pharmacokinetics, pharmacodynamics, and neonatal clinical trials.

Prof. Johannes N. van den Anker
Dr. Klaus Rose
Guest Editors

Submission

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. Papers will be published continuously (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are refereed through a peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Children is an international peer-reviewed Open Access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. For the first couple of issues the Article Processing Charge (APC) will be waived for well-prepared manuscripts. English correction and/or formatting fees of 250 CHF (Swiss Francs) will be charged in certain cases for those articles accepted for publication that require extensive additional formatting and/or English corrections.

Keywords

- Better Medicines for Children
- Paediatric Drug Development
- Paediatric Formulations
- Juvenile Animal Studies in Drug Development
- Age-Specific Formulations
- Paediatric Clinical Pharmacology
- Neonatal Clinical Pharmacology
- Developmental Pharmacology
- Pharmacokinetics
- Pharmacodynamics
- Neonatal Clinical Trials
- Inclusion of paediatric aspects in drug development
- Children and history of pharmacy
- Children and history of medicine
- Children and society

For information regarding sponsoring opportunities, please contact Martin Austin.
Email : mcaustin@transformrx.com

Registration InformationTo register with this conference, please follow this link. If you need assistance, please e-mail the Conference Secretariat.


Main Conference incl. Pre-Conference Workshops 1* & 2**

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 2000
29 Oct – 4 Dec 2016 - CHF 2200
From 5 Dec 2016 - CHF 2400

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 1000
29 Oct – 4 Dec 2016 - CHF 1100
From 5 Dec 2016 - CHF 1200


Main Conference incl. Pre-Conference Workshop 1*

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 1500
29 Oct – 4 Dec 2016 - CHF 1650
From 5 Dec 2016 - CHF 1800

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 750
29 Oct – 4 Dec 2016 - CHF 825
From 5 Dec 2016 - CHF 900


Main Conference incl. Pre-Conference Workshop 2**

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 1500
29 Oct – 4 Dec 2016 - CHF 1650
From 5 Dec 2016 - CHF 1800

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 750
29 Oct – 4 Dec 2016 - CHF 825
From 5 Dec 2016 - CHF 900


Conference Only

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 1000
29 Oct – 4 Dec 2016 - CHF 1100
From 5 Dec 2016 - CHF 1200

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600


Workshops 1* & 2**

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 1000
29 Oct – 4 Dec 2016 - CHF 1100
From 5 Dec 2016 - CHF 1200

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600


Workshop 1*

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 250
29 Oct – 4 Dec 2016 - CHF 275
From 5 Dec 2016 - CHF 300


Workshop 2**

Registration Fee in CHF

Industry
By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600

Academia
Regulatory Authorities
Patient Organisation

By 28 October 2016 - CHF 250
29 Oct – 4 Dec 2016 - CHF 275
From 5 Dec 2016 - CHF 300


Networking Event Evening of February 2: Complimentary

* Pre-Conference Workshop Commercial Drug Development MasterClass (Morning of 1 February 2016)
** Pre-Conference Workshop Paediatric Drug Development MasterClass (Afternoon of 1 February 2016)Registration fees include

• Attendance to all sessions
• Conference Documents
• Lunch
• Coffee breaks
• Networking Event

Confirmation

Upon receipt of the correct registration fee, 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.

Cancellation/Name change

Refund of fees, less 25% administrative charges, can be applied for in writing until 18 December 2016 to the Administrative Secretariat. After this date no refund will be possible. Substitutions of attendees can be made at any time. For any change of names, a fee of CHF 30 will be charged.

Students

Students have the possibility to apply for a special discount. Please send your application together with a copy of a valid student card. The rate for students is CHF 120.

Responsibility

The participant acknowledges that he/she has no right to lodge damage claims against the organizers should the holding of the congress 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.
By finishing the application, the participant declares that he/she agrees to its personal and company data being processed by MDPI and that this data may be used for information purposes on congresses and events in related fields organized by MDPI. In the opposing case, the participant should notify MDPI at the time of returning the signed application.

For inquiries, please contact Conference Secretariat.

Third Annual Conference on Drug Development in Pediatric and Rare Diseases: Successes & Opportunities - 2/3^rd February 2017 Basel, Switzerland.

Day 1

Time	Activity	Speaker
8:00	Breakfast and Registration
8:45	Welcome	Klaus Rose & John van den Anker
Session 1: Success Stories 1 - Pediatric Drug Development. Moderation: Swissmedic & Koenrad Norga
9:00	Pediatric Drug Development	Adina Tokojan
9:30	Update on the March of Dimes	Michael Katz
10:00
10:30	Coffee Break
11:00	Pediatric Drug Development	Hubert Caron
11:30	Neonatal Pulmonary Drug Delivery Devices	Trish Smith
12:00	Hands-on diagnosis & treatment of rare diseases	Jean-Marc Nuoffer
12:30	Lunch Break & Exhibitors Hall Visit
Session 2: Regulatory Challenges. Moderation: Phil Walson & Michael Katz
13:30	EMA/PDCO perspective	Koenraad Norga
14:00	Pediatric perspectives in drug development: Switzerland	Hulya Oezsahin
14:30	Industry Perspective	Solange Rohou
15:00	Adopting the last therapeutic orphans: an update on the latest developments	John van den Anker
15:30	Discussion
16:30	Refreshments for die-hards and networking
18:00	Come Together

Day 2

Time	Activity	Speaker
8:45	Welcome	Klaus Rose & John van den Anker
Session 3: Regulatory and scientific challenges - Strategic Thoughts. Moderation: Martin Austin
9:00	From research to bedside: academic drug development- reality, promise, successes	Phil Walson
9:30	What regulatory authorities do in pediatric drug development – and what they should do	Klaus Rose
10:00	Coffee Break
10:30	Demonisation of commercial drug development: why more entrepreneurs are needed and how to do it	Martin Austin
11:00	Round Table Discussion
12:30	Lunch Break & Exhibitors Hall Visit
Session 4: Technical Advances & Challenges. Moderation: Marc Pfister
13:30	Pediatric Formulations	Norbert Poellinger
14:00	Scaling Models in pediatric PK/PD	Martin Graham
14:30	Bottom-up meets top-down: Complementary PBPK and PopPK modeling for regulatory approval of a dosing algorithm of valganciclovir in very young children.	Karin Jorga
15:00	Wrap-up
16:30	End of day 2

The conference will be preceded by a half day Masterclass on Commercial Drug Development by Martin Austin (morning of February 1) and by a Masterclass on Pediatric Drug Development by Klaus Rose (afternoon of February 1).