What is relevant for approval? What's "new"? - an overview
Webcode 24112459
Dr. Uwe Goßlar
Granzer Regulatory Consulting & Services GmbH, Munich
Consultant for Medical Device Development and Regulatory Affairs
After finishing his PhD and postdoctoral research in Immunology Dr Goßlar started in 2000 his industry career in the biotech business where he held various positions including drug regulatory affairs. In 2008 he joined Sandoz GmbH.
Prior to joining Granzer, Uwe Goßlar was globally responsible for all medical device aspects of Novartis/Sandoz‘ biosimilar projects. He was personally involved in successful development and certification/licensing of pen- and autoinjectors (e.g. CE marking/510(k)/MDL/ISO13485 and MDSAP certification) as well as marketing authorisation procedures for drug-device combination products including pre-filled pens and syringes in a variety of different markets globally (e.g. Centralized Procedure/NDA/BLA).
Dr Goßlar joined Granzer Regulatory Consulting & Services in July 2019 as consultant for medical device development and regulatory affairs.
More information please click here.
Carina Simons
Quality Expert, Bonn, GERMANY - requested -
Carina Simons is a pharmacist and completed her M.D.R.A. in Bonn in 2019. Since 2016, she has been working in drug regulatory affairs in the evaluation of drug quality with a focus on inhaled products. She has been a member of the INH Working Party (Inhalations) of the EDQM since 2023.
Dr Mustafa A. Zaman
Granzer Regulatory Consulting & Services GmbH, Munich, GERMANY
Senior Consultant CMC
Dr Zaman qualified as a Pharmacist after initially gaining a BPharm (Hons) degree and later a PhD in Drug Delivery - both from King's College London.
He has over 20 years' experience, where 10 years were spent working for the MHRA (UK) as a Senior Pharmaceutical Reviewer/Assessor. He has also worked with several companies including PAREXEL Consulting, GSK and GENPACT.
Mustafa joined Granzer Regulatory Consulting & Services as a Senior Consultant in November 2022.
Mustafa has experience in leading strategic, technical and / or process issues for a wide range of therapeutic/product types, including new chemical entities, generic products, combination products, drug-device combinations and clinical trials applications. He is experienced in European and US procedures including regulatory authority meetings, Clinical Trial Applications and Market Authorisations.
Mustafa is a member of the MHRA Analytical Quality-by-Design (AQbD) Working Party, a Member Centre of Pharmaceutical Medicine Research (CPMR) Scientific Advisory Board at King's College London and holds four academic (Honorary) posts at three UK Universities.
More information please click here.
Roman Oravec
LaNova Consulting Ltd., Vienna, AUSTRIA
Project Director Medical Development
Roman has an academic education in molecular biology and substantial experience in the scientific, medical, and pharmaceutical industries since 2001 based on research activity in the field of development of molecular diagnostic techniques for thyroid cancer and based on his experience in regulatory affairs and quality management, including MP/MD/IVD registration activities and (regulated) clinical development.
More information please click here.
13/11/2024
13/11/2024
09:00 am till 04:00 pm - online training
You may dial in 30 min before the training starts
online
online
Veranstaltung - 990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Veranstaltung - 990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Development of inhaler/inhalants/pulmonal drugs: An overview of the regulatory/quality (CMC), device and clinical requirements - what is relevant for approval? what's "new"? Four proven experts will discuss all relevant aspects with you and your colleagues from the industry.
You desire a comprehensive overview of the latest advancements and requirements in the field of inhaler and inhalant development?
Don't miss out on this opportunity to enhance your knowledge and skills in the field.
Our experts with industry, authority and consulting experience will ensure you are up-to-date with the current requirements, standards and practices, especially from a regulatoy and technical point of view.
After participating the course you have received a summary of the updated guideline ("new" vs "old" aspects) and an overview on the current requirements with a focus on RA/quality/CMC, device and clinical aspects.
You will benefit in particular from the presentation of the case study which illustrates the application of the respective guidelines in a "real-world scenario".
Your will in particular benefit from
09:00
Dr Mustafa A. Zaman and Dr Uwe Goßlar
09:30
Carina Simons
10:15
10:30
Carina Simons
11:00
Dr Uwe Goßlar
12:00
13:00
Dr Mustafa A. Zaman and Dr Uwe Goßlar
14:15 Break
14:30
Roman Oravec
15:15
16:00 End of seminar day
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
Eine Frage der Abgrenzung: Arzneimittel, kosmetische Mittel, Medizinprodukt oder doch Nahrungsergänzungsmittel?
Sie wünschen sich transparente Handlungsanweisungen für Ihr qualitatives und quantitatives Nutzen-Risikomanagement? Auf ...
Der viertägige Online-Intensivlehrgang vermittelt Ihnen umfassendes Know-how im Qualitätsmanagement der Klinischen Forsc...
CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality d...
Get your know-how on creating and maintaining quality data for biotech products in our online training.
Are you interested in our international continuous education programme? We provide a variety of specialised courses.
Details
We are now officially certified to ISO 9001 and ISO 21001 standard.
Details
More than 4,500 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.
Details
