קטגוריה: ניסויים קליניים
Designing Your Clinical Trial
Strategic Planning and IB Preparation Towards an Efficient Clinical Development

תאריך: 16 ינואר 2019
מיקום הקורס:  משרדי ביופורום, גולדה מאיר 3, נס ציונה. קומה 4
שפת הקורס: אנגלית
משך הפעילות: חצי יום לימודים
שעות: 9:00-11:30
נקודות זכות: 0
מק''ט: 191009
 
http://www.pulseem.com/Pulseem/ClientImages/2700/courses/191009.jpg

The number of compounds developed, and amount of clinical studies performed were increased dramatically over the years, but only few compounds make it to the market.
Therefore, it is crucial to use several strategic planning tools and compile well-organized essential documents to produce cost-effective and efficient drug development programs.
The seminar is intended to present the audience with the current challenges and opportunities in clinical development and discuss the importance of clinical development plan and concise IB compilation in creating an efficient drug development process & successful submission.


Agenda

9:00-9:15 Gathering
9:15-10:15 Strategic Considerations in Compiling a Clinical Development Plan
Yossi Gilgun-Sherki, Ph.D, MBA., Independent Clinical and Scientific Consultant

The failure of so many clinical programs emphasize the need for appropriate planning before and during the clinical development. One of the major documents for doing that is the clinical development plan that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity during the clinical program.
Using such a document as part of a comprehensive product development strategy provides a valuable tool that will aid to improve decision-making throughout the process, organize all activities during development towards submission, support synchronization between the different professional disciplines at the appropriate time and assist to reduce costs and increase efficiency and probability of success.


10:15-10:30 Break
10:30- 11:30 The Development Program's Core Document
An Open Discussion About Writing Investigator's Brochures

Shiri Diskin, Ph.D., VP Medical Writing, Bioforum

The Investigator's brochure is the core document of the entire development program. It presents all available information about the product, spanning clinical and non-clinical data and serves as the main source for product safety information until (and sometimes after) the product is approved for marketing and there is an official regulator-approved label.
The brochure provides an overview of the entire development program and is a "living" document, updated at least annually. Its compilation process can serve as a tool for the sponsor to review cross-study information and plan ahead.
Brochures have a uniform format (although not completely rigid), the familiarity with which streamlines the writing process and helps prevent the gaps in information in the final document. Brochures written correctly facilitate clear and rapid communication within the Sponsor and with external service providers. Ultimately, they form the basis for communications with regulators, investors and payors.



About Speakers
http://www.pulseem.co.il/Pulseem/ClientImages/2700/shiri.jpg Shiri Diskin, Ph.D
VP, Medical Writing

Shiri holds a Ph.D. in cell, molecular and developmental biology from Tufts University and a B.Sc. in life sciences from Tel-Aviv University. She has been a medical writer since 2009. Shiri worked as a medical writer and medical writing team leader at Teva until 2014. Since then, she has been working as an independent instructor and consultant of medical writing. Shiri is experienced in managing medical writing projects of early and late phase product development. Her expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents such as investigator’s brochures and summaries of efficacy and safety. Shiri is experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines.
http://www.pulseem.com/Pulseem/ClientImages/2700/Yossi%20Gilgun.jpg Yossi Gilgun-Sherki, PhD, MBA
Independent Clinical and Scientific Consultant

Yossi has more than 20 years of experience in academic research & the pharmaceutical industry, leading a broad spectrum of drug development activities & biotech projects overseeing in all stages and in various companies.He is serving as a Clinical & Scientific Advisor, where he is providing clinical, scientific, medical and overall R&D consultation on drug/medical device development, with specific focus on pre-clinical and clinical studies design to biotech and pharma companies.
In his previous position Dr. Gilgun-Sherki has served as Head of Specialty Products at Dexcel Pharma, where he was leading the R&D activities. Yossi has served as Global Clinical Program Leader & Senior Clinical Scientist at Teva Global Innovative R&D group.Dr. Gilgun-Sherki holds a PhD degree from the Sackler Faculty of Medicine, Tel Aviv University, in neuropharmacology, and an MBA degree from The Open University of Israel. He is a (co)author of over 40 publications and book chapters, and an inventor of 6 patents.



Target Audience:

This symposium is a perfect learning session for Sponsors of phase I-III trials.

http://www.pulseem.co.il/Pulseem/ClientImages/2700/reg-noww.pngBioforum clients: First participant free of charge
General Admission:
500 NIS +VAT

Space is limited. Registration will be pre-approved by Bioforum


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