European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

• Date:
  Thursday, 4 December 2014, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

EMA/EFPIA workshop is planned for 4-5 December 2014 to discuss the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products.Registration: please register by 19 September 2014 using the registration form provided.

Documents

Report from the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and life...

Reference Number: EMA/117491/2015

Agenda - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on the importance of dose finding and dose selection for the successful development, licensing and lif...

Reference Number: EMA/341714/2014

Presentation - Workshop opening (Rob Hemmings, Efthymios Manolis)

Summary:

European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

Presentation - Dose selection in drug development and regulation: possible future direction (Richard Lalonde, Donald Stanski)

Presentation - Dose response assessments: guidance, experience, expectations (Vikram Sinha)

Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby)

Presentation - Sarm I/Tadalafil pgase II combination study for erectile dysfunction: modeling and simulation to optimize study design (Charles Benson)

Presentation - Regulatory comments: pharmacometric principles in dose finding (Terry Shepard, Sofia Friberg Hietala)

Presentation - An adaptive dose-finding study in postoperative dental pain. MCP-Mod (Bjà¶rn Bornkamp)

Presentation - Averaged model based decision making for dose selection studies (Yasunori Aoki, Bengt Hamrà©n, Daniel Rà¶shammar, Andrew C. Hooker)

Presentation - Model based dose finding: discussion of presentations given by Bjà¶rn Bornkamp and Andrew Hooker (Norbert Benda)

Presentation - Meta-analyses of clinical dose response (N. Thomas, D. Roy, V. Somayaji, K. Sweeney)

Presentation - Ph 2/3 trial for selepressin in the treatment of vasopressor-dependent septic shock (Scott Berry)

Presentation - Ph 2/3 trial for selepressin (Martin Posch)

Presentation - Session 2 summary: designs and methods (Jose Pinheiro)

Presentation - Dosing: examples from antipsychotics (Luca Pani)

Presentation - Ph2a dose selection based on the relationship between PK and target occupancy (Mona Alameddine, Patricia Sanwald Ducray)

Presentation - A systems pharmacology perspective on the clinical development of fatty acid amide hydrolase inhibitors for pain (Piet van der Graaf)

Presentation - Dose finding for a β-lactam – β-lactamase inhibitor combination (Shampa Das, Astra Zeneca)

Presentation - Mechanism-based PKPD-models for selection of dosing regimens for antibiotics (Lena Friberg, Anders Kristoffersson, Elisabet Nielsen)

Summary:

European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

Presentation - General principles of antiviral dose selection (Filip Josephson)

Presentation - Cabozantinib (Cometriq) (Frans Opdam)

Presentation - Shifting the MTD paradigm in oncology (Kevin Smart, Georgina Meneses-Lorente)

Presentation - An oncology systems pharmacology approach to dose selection (James Yates)

Presentation - Agonists with different levels of affinity (Peter Mol)

Presentation - Dose-finding in the cardiovascular therapeutic area: the novel oral anticoagulants (Antonio Gà³mez-Outes)

Presentation - Key learnings from otamixaban development (Christophe Gaudin)

Presentation - Dose - response - anticoagulants (Robert Temple)

Presentation - Use of dose-exposure-response model in immunology/transplantation: general considerations and case study (T Dumortier, M Looby, Y Wang)

Presentation - Regulatory and physician view (Lisbeth Barkholt)

Presentation - Regulatory view (Flora Musuamba Tshinanu)

Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - children (Dirk Mentzer, Ine Rusten)

Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - Children (Anne Brochot)

Presentation - D-E-R characterisation in dose selection, labelling and B/R assessment: focus on the elderly (Terry Shepard, Sue Morgan)

Presentation - Sub population: the elderly - How can modelling and simulation inform understanding of safety and efficacy? (Amy S. Y. Cheung)

Presentation - Dose and schedule determination and amendments of EU centrally approved products (CAPs) (Falk Ehmann)

Presentation - Impact of D-E-R information on regulatory approval and post-authorisation commitments: FDA perspective (Yaning Wang, Vikram Sinha)

Presentation - Regulatory evaluation and perspectives on dose-exposure-response information in new drug applications (Naoyuki Yabana, Naomi Nagai)

Presentation - Dose selection in drug development and regulation: possible future direction concluding industry thinking (Richard Lalonde, Donald Stanski)

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