BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T153707Z UID:341064ae-7bae-4034-b64f-33e887195452 DTSTART:20210319T090000 DTEND:20210320T090000 CLASS:PRIVATE DESCRIPTION:
This seminar provides Professionals working in this area wit h:
\n\nCombination products are especially challenging to register and maintain since they consist of two or more regulated compo nents covered by different and usually independent sets of regulations in both the EU and US and various other regions.
\n\nDelegates working in this area must keep abreast of current and new legislation in this comp lex area to ensure a good regulatory strategy and compliance of their prod ucts.
\n\nDocument ation requirements and interfacing
\n\nA high level overview to Combination Products
\n\nIncluding an interactive group session reviewing individual expectations
\n\nIntroduction to Drug/Device Regulations
\n\nDuring this introductory session\, delegates will gain a complete guide to the status and impact of the latest guidelines for co mbination products. Examples (company specific) of combination products wi ll also be discussed to gain insights into their variety and complexities. Regulatory Requirements for: US and EU
\n\nCE Marking\, 510 K and PMAs general Overview
\n\n< ul>\nLife Cycle Management
\n\nIncluding a walkthrough of expected out
comes for all case study exercises
\nWrap up of day 1 &\; Q&\;A
'\;s
Overview Combination product Regulation and CTD dossier requirments<
/strong>
EU and US (A comparative review)
\n\nClarifying the regulatory requirements of combinati on products and addressing life-cycle management
\n\nCASE STUDY 2
\n\nCASE STUDY 3 p>\n\n
Wrap up of day 2
\n\nFinal Q&\;A &\; Summary o
f '\;working smart'\; with Combination Products
\n
\n 
\;
Salma Michor \;is founder and CEO of Michor Consu
lting Schweiz GmbH\, serving such clients as Johnson &\; Johnson\, Nova
rtis\, Shire\, Pfizer and Colgate Palmolive. Previously\, Michor worked fo
r Chiesi-Torrex\, Wyeth Whitehall Export Croma Pharma GmbH. She teaches re
gulatory affairs and clinical strategies at the University of Krems\, Aust
ria\, and is an independent expert to the European Commission. She holds a
PhD in thermal process engineering and an MSc in food and biotechnology f
rom the University of Applied Life Sciences in Vienna\, Austria\; an MSc f
rom King'\;s College\, University of London in food technology\; and an
MBA from Open University\, and has earned the RAC (EU)\, CQA and is a Cha
rtered manager.
\n
\nPlease contact Marilyn Turner: Phone: +1 92
9 900 1853  \;Email: marilyn.turner [a] nyeventslist.com for registrat
ions