קטגוריה: הכשרות מקצועיות
Breakfast symposium:
Early Meetings with Regulators
מרצים: Ms. Catrin Ball-Rosen, גב' תחיה טואף
תאריך: 3 יולי 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
התכנסות והרשמה: 8:30
עלות: 500 ₪ + מע"מ; חינם ללקוחות ביופורום
נקודות זכות: 1
מק''ט: 191028
 
http://www.pulseem.com/Pulseem/ClientImages/2700/bioforum-datalogo.png
http://www.pulseem.com/Pulseem/ClientImages/2700/courses/Early%20Meetings%20with%20Regulators.jpg

Agenda

9:00-9:15 Gathering
9:15-10:15 Engage a Successful Partnership & Collaboration with the FDA
Techiya Toaff, Regulatory Consultant

The pre-IND meeting is very valuable in planning a drug development program, especially if sponsors' questions are not fully answered by guidance’s and other information provided by FDA. The Value of early interactions with FDA is an opportunity for Sponsors to receive direct feedback on their product from the FDA and can help to prevent clinical hold issues from arising. The pre-IND meeting, is a milestone meeting that is encouraged by FDA. This meeting has the potential to save time and money both in the short and long run and can really shape the overall strategy for drug development for the compound under study.
10:15-10:30 Break
10:30- 11:30 “Pendant to the pre-IND meetings at the FDA" in Europe: scientific advice meeting, protocol assistance meeting, pre-submission meetings
Catrin Ball-Rosen, Freelance EU Regulatory Affairs Consultant

Both the European Medicines Agency (EMA) and EU Member State National Competent Authorities (NCAs) offer scientific advice (SA) to applicants from the early stages of the development process. Scientific Advice covers all aspects of development of a medicine from
quality of the manufacturing process to non-clinical questions, clinical aspects and regulatory and significant benefit for orphan designated medicines. EMA offers assistance to applicants in putting their scientific-advice or procedural-advice requests together through pre-submission meetings. SA(s) aimed at ensuring the most appropriate studies are conducted, avoiding major objections related to the study design during the MAA evaluation.
This presentation aims to describe the scope and SA procedure & the company’s preparation for it.

About Speakers
http://www.pulseem.com/Pulseem/ClientImages/2700/Techiya%20Toaff.jpg Techiya Toaff
Regulatory  Consultant

Her experience covers over 18 years in the pharmaceutical drug development field in which she has assisted international companies in obtaining licensing agreements with the USA Food & Drug Administration. Previously she served as regulatory project manager at the FDA and gained extensive experience and knowledge in all phases of the regulatory process leading to marketing authorization. Specialized FDA experience with experience coordinating and leading scientific projects in collaboration with regulatory staff and multidisciplinary, matrix designed teams, to include clinicians, chemists, biologists, toxicologists, pharmacologists, and/or statisticians, in the drug review process; and ensuring legal, regulatory and policy requirements/compliance associated with drug development.
Prior to her FDA position, she served in several clinical operations project management roles providing customer-focused leadership, in all phases of drug development.
She holds a R.N. degree and a M.S.H.S. in clinical research administration from the George Washington University in Washington D.C.
She is a Member of the Alpha Eta Honor Society, a prestigious American national honor society, as recognition of leadership capabilities and high attainments in the health professional field.
http://www.pulseem.com/Pulseem/ClientImages/2700/courses/Catrin%20Ball-Rosen.jpg

Catrin Ball-Rosen
Freelance EU Regulatory Affairs Consultant

Her experience covers over 18 years in the pharmaceutical industry with focus on advanced EU pre-authorisation phase in terms of CNS innovative products.

  • Planning & coordination clinical trial applications in the EU
  • Planning and coordination of EMA Marketing Authorisation Applications including labeling negotiations
  • Planning & coordination of Brexit related submissions
  • Leading an EU clinical trial task force to adapt internal processes for preparedness towards new EU CTA regulation
  • Development and implementation of various working procedures / SOPs in line with EU regulations

Since 2016 she became an EU RA consultant supporting international companies in terms of:
She holds a BS Pharm degree from the Johann-Wolfgang von Goethe University, Frankfurt Germany and a M.Sc. degree from Sackler Faculty of Medicine Tel-Aviv University, Tel-Aviv, Israel



http://www.pulseem.co.il/Pulseem/ClientImages/2700/reg-noww.pngTarget Audience
This symposium is a perfect learning session for Sponsors of phase I-III trials

Bioforum clients: First participant free of charge
General Admission: 500 NIS +VAT

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


http://www.pulseem.com/Pulseem/ClientImages/2700/bioforum-datalogo.pngFor more information please contact:
Shir Abramovitz
3 Golda Meir St., Weizmann Science Park, Ness Ziona 70400, Israel
Tel: +972-8-3730500, ext.778 | Mobile: +972-54-7642683 | Email: Shir.abramovitz@bioforumgroup.com

  • שם מלא
  • דוא''ל
  • טלפון
  • הודעה
שלח