会议日程

天 1 2016 年 04 月 06 日

9:00 AM — 12:30 PM

3rd ICH Information Day

9:00 AM — 12:30 PM

EM02-Moving-from-Risk-Management-to-Benefit-Risk-Management-Embedding-Pharmacovigilance-Principles-into-the-Product-Life-Cycle

9:00 AM — 12:30 PM

EM03-Interactions-between-Regulatory-and-Intellectual-Property-Product-Liability-and-Data-Privacy

9:00 AM — 12:30 PM

EM04-Analysis-of-Safety-Data-from-Clinical-Trials

9:00 AM — 12:30 PM

EM05-EU-Risk-Management-Plans-Using-Pre-Clinical-Data-to-Write-the-Module-SVII-of-the-RMP-Part-II-Safety-Specifications

9:00 AM — 12:30 PM

EM06-Hot-Topic-in-Pharmacovigilance-and-Adverse-Reaction-Reporting

9:00 AM — 12:30 PM

Introduction-to-the-Regulation-of-Medical-Devices-and-Medical-Software

11:00 AM — 12:30 PM

German Satellite Session - Regulatory and Scientific Contributions of BfArM and PEI to Pharmaceutical Innovation

1:30 PM — 3:00 PM

4:00 PM — 5:45 PM

天 2 2016 年 04 月 07 日

9:00 AM — 10:30 AM

Challenges and Best Practices for Writing Lay Summaries of Clinical Study Results

9:00 AM — 10:30 AM

PRIME Initiative Launch: Fostering Timely Access for Patient-Focused Drug Development

11:00 AM — 12:30 PM

Communicating Benefit-Risk Information in Risk Management Plans to Medical Professionals and the General Public

11:00 AM — 12:30 PM

The Needs of the Payers Shape the Evidence for Market Access

2:00 PM — 3:30 PM

Innovative Developments in Medical Technology

2:00 PM — 3:30 PM

Shall HTA Depend on Randomised Controlled Trials (RCT) or Real-World Data (RWD) or Both?

4:00 PM — 5:30 PM

Combination Products

4:00 PM — 5:30 PM

Import Testing: Current Requirements and Opportunities to Simplify Access of Medicines for Patients

天 3 2016 年 04 月 08 日

9:00 AM — 10:30 AM

Content and Context of IDMP

9:00 AM — 10:30 AM

How Can Three Parties- Payers, Industry and HTA - Make Agreements and Share the Economic Risk?

11:00 AM — 12:30 PM

From Tradition to Regulation – Globalisation of Herbal Medicines

11:00 AM — 12:30 PM

MAPPs: The IMI ADAPT SMART Project

11:00 AM — 12:30 PM

Self-Care Medical Devices: Shifting Borders between Devices and Pharma?

11:00 AM — 12:30 PM

Use of Extrapolation in Paediatric Drug Development: Can We Achieve Global Agreement through the Revision of the ICH E11 Paediatric Guideline?

2:00 PM — 3:30 PM

MAPPs: The IMI ADAPT SMART Project

4:00 PM — 5:30 PM

European Relative Effectiveness Assessments

4:00 PM — 5:30 PM

IVDs and Companion Diagnostics

28th Annual EuroMeeting

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