3rd international congress of Integrated Paediatric Drug Development
2
© sonya etchison - Fotolia.com To Register T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.paediatrics-congress.com/SS INTEGRATED PAEDIATRIC DRUG DEVELOPMENT Writing a PIP • Preparing comprehensive clinical studies • Conducting successful clinical trials 13th – 15th April 2011 | Dorint Hotel Sanssouci Berlin-Potsdam | Germany 3rd international congress Researched and developed by Media Partners Supported by Hear international case studies from leading companies and institutes: • Bayer Schering Pharma AG, Germany • F. Hoffmann-La Roche Ltd., Switzerland • Almirall R&D, Spain • Federal Institute for Drugs and Medical Devices, Germany • Merck Sharp & Dohme Limited, United Kingdom • Astellas Pharma Global Development Europe, The Netherlands • Paul-Ehrlich Institute, Germany • Granzer Regulatory Consulting & Services, Germany • Omnicare Clinical Research, Germany • University Children’s Hospital Heidelberg, Germany • Dutch Patent Office, The Netherlands • INTERLAB central lab services – worldwide, Germany • Only for children pharmaceuticals, France • Novartis Pharma AG, Switzerland • Learn how to develop a successful Paediatric programme in line with EMA and FDA requirements • Benefit from your peers' experiences in successfully translating a PIP into clinical trials to ensure a smooth implementation • Find out key requirements from pharmacology for the successful implementation of your trials in neonates, infants and children to avoid high failure rates • Examine the practical challenges from preparing your trials such as toxicology, informed consent and palatable formulations Visit our download center for free white papers, articles and much more! www.paediatrics-congress.com/SS "Excellent package of interesting and relevant topics together with well experienced speakers!" Dr. Frank Hoffmann, Manager Regulatory Affairs, Grünenthal GmbH Chairmen: Dr. Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services Join our interactive workshops: A The PIP process – an operative hands-on workshop B Clinical pharmacology in neonates, infants and children C Outsourcing the paediatric investigation plan: How to optimise the cooperation in developing the PIP D Practical considerations in regards to paediatric studies: design, challenges, strategies and operational tips Learn from these experts amongst others: Dr. Dirk Mentzer, Head of Pharmacovigilance, Paul-Ehrlich-Institute & PDCO Dr. Pauline Walstra, Director Regulatory Affairs Development, Astellas Pharma Global Development Europe Dr. Gonzalo de Miquel, Director Respiratory Therapy Area, Almirall R&D Dr. Corina Becker, Expert Clinical Pharma-cokinetics, Clinical Pharmacology representative in the BSP Pediatric Task Force, Bayer Schering Pharma AG SAVE up to € 290,- with our Early Birds if you book by the 28th January 2011! Special case studies on: • Paediatric inhalation devices • Paediatric leukemia • Paediatric organ transplantation medicine Dr. Bruno Reigner, Senior Clinical Pharmacologist, F. Hoffmann-La Roche Ltd. CanBiotech R&D Outsourcing Capital Sourcing Competitive Intelligence
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Transcript of 3rd international congress of Integrated Paediatric Drug Development
© sonya etchison - fotolia.com
To register T +49 (0)30 20 91 33 30 | f +49 (0)30 20 91 33 12 | E [email protected] | www.paediatrics-congress.com/SS
Integrated PaedIatrIc Drug DevelopmentWriting a PIP • Preparing comprehensive clinical studies • Conducting successful clinical trials
13th – 15th April 2011 | Dorint Hotel Sanssouci Berlin-Potsdam | Germany
3rd international congress
researched and developed by
media Partners
supported by
Hear international case studies from leading companies and institutes:
• Bayer Schering Pharma AG, Germany
• F. Hoffmann-La Roche Ltd., switzerland
• Almirall R&D, spain
• Federal Institute for Drugs and Medical Devices, Germany
• Merck Sharp & Dohme Limited, united Kingdom
• Astellas Pharma Global Development Europe, the netherlands
• Paul-Ehrlich Institute, Germany
• Granzer Regulatory Consulting & Services, Germany
• Omnicare Clinical Research, Germany
• University Children’s Hospital Heidelberg, Germany
• Dutch Patent Office, the netherlands
• INTERLAB central lab services – worldwide, Germany
• Only for children pharmaceuticals, France
• Novartis Pharma AG, switzerland
• learn how to develop a successful Paediatric programme in line with EMA and FDA requirements
• Benefit from your peers' experiences in successfully translating a PIP into clinical trials to ensure a smooth implementation
• Find out key requirements from pharmacology for the successful implementation of your trials in neonates, infants and children to avoid high failure rates
• examine the practical challenges from preparing your trials such as toxicology, informed consent and palatable formulations
visit our download center for free white papers, articles and much more! www.paediatrics-congress.com/SS
"Excellent package of interesting and relevant topics together with well
experienced speakers!"
Dr. frank Hoffmann, Manager regulatory Affairs, Grünenthal GmbH
Chairmen:
Dr. Klaus rose, Principal Consultant, Granzer Regulatory Consulting & Services
Join our interactive workshops:
A the PIP process – an operative hands-on workshop
B Clinical pharmacology in neonates, infants and children
C outsourcing the paediatric investigation plan: How to optimise the cooperation in developing the PIP
D Practical considerations in regards to paediatric studies: design, challenges, strategies and operational tips
Learn from these experts amongst others:
Dr. Dirk Mentzer, Head of Pharmacovigilance, Paul-Ehrlich-Institute & PDCO
Dr. Pauline Walstra, Director regulatory Affairs Development, Astellas Pharma Global Development Europe
Dr. Gonzalo de Miquel, Director respiratory Therapy Area, Almirall R&D
Dr. Corina Becker, Expert Clinical Pharma-cokinetics, Clinical Pharmacology representative in the BSP Pediatric Task force, Bayer Schering Pharma AG
SAVe
up to €
290
,- with
our
Early
Birds i
f you b
ook by
the
28th
Jan
uary
2011
!
Special case studies on:• Paediatric inhalation devices• Paediatric leukemia• Paediatric organ transplantation medicine
Dr. Bruno reigner, Senior Clinical Pharmacologist, F. Hoffmann-La Roche Ltd.
CanBiotechR&D Outsourcing
Capital Sourcing
Competitive Intelligence
13th – 15th April 2011 | Dorint Hotel Sanssouci Berlin-Potsdam | Germany
Integrated PaedIatrIc Drug Development
3rd international congress
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4 Ways to Register
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Please indicate choice of workshop on Wednesday, 13th April 2011Workshop A I Workshop B I Workshop C I Workshop D
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Early Bird(Book and pay by the 28th January 2011)
Standard Price
Platinum Package 2 day congress plus 2 workshops Save € 290,- € 2.609- +vat € 2.899,- + vat
Gold Package 2 day congress plus 1 workshop Save € 260,- € 2.339,- +vat € 2.599,- + vat
Bronze Package 2 day congress € 2.199,- + vat
Workshop Day € 1.399,- + vat
Congress Packages
A: The PIP process – an operative hands-on workshopB: Clinical pharmacology in neonates, infants and childrenC: Outsourcing the paediatric investigation plan: How to optimise the cooperation in developing the PIPD: Practical considerations in regards to paediatric studies: design, challenges, strategies and operational tips
slideshare
Venue and Accommodation
Dorint Hotel Sanssouci Berlin-Potsdam Jägerallee 2014469 Potsdam, Germanytel.: +49 (0)331 2740Fax: +49 (0)331 2741005email: [email protected]/potsdam
Potsdam: city of Prussian kings, of palaces and gardens – a historic city with many stories
to tell. and right in the heart of things – the Dorint Hotel sanssouci Berlin-Potsdam. Here you will expect comfortable rooms, daylight-filled meeting rooms, culinary delights and a team of employees that go the extra mile to make sure that you feel happy. whatever draws you to Potsdam, our team looks forward to welcome you in the Dorint Hotel sanssouci Berlin-Potsdam!
Accommodation: a limited number of reduced rate rooms are available at the conference hotel. accommodation canbe booked by calling the central reservation number.Please always quote the booking reference IQPC-Berlin. Hotel accommodation and travel costs are not includedin the registration fee.
