2024-06-21 2024-06-21 , online online, 1,590 € zzgl. MwSt. Dr. Anika Schröter https://www.forum-institut.de/seminar/24092473-webcast-series-from-lab-to-launch-technical-cmc-and-non-clinical-development-of-rna-dna/referenten/24/24_09/24092473-pharma-seminar-the-a-z-of-rna-based-drugs-and-oligonucleotides_schroeter-anika.jpg Webcast series "From Lab to Launch: Technical CMC and Non-Clinical Development of RNA/DNA-based drugs"

RNA-/DNA-based drugs: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.

Topics
  • Concept: Five weekly live webcasts à 2 hours with longtime experienced speakers
  • Topics covered: CMC and non-clinical aspects, challenges during technical drug development incl. analytical tools and formulation principles, regulatory requirements
  • Your benefits: Possibility to directly interact with the speaker; you will receive a certificate after each session; you are unable to attend one of the sessions? benefit from the recording of each webcast!


Who should attend
The target audience for this training comprises professionals in the pharma & healthcare sector as well as scientists from research institutes/universities who are involved in technical CMC or non-clinical development of RNA/DNA-based drugs incl. oligonucleotides.
Aims and objectives
You desire comprehensive knowledge and understanding of the key aspects involved in the technical CMC and non-cliinical development of RNA/DNA-based drugs incl. oligonucleotides also covering regulatory aspects?

The webcast series will delve into the principles and challenges encountered during the CMC and non-clinical drug development phase, including the formulation of these drugs. It will also cover the regulatory requirements that need to be met for the successful approval.
Furthermore, the course will introduce and explain the concept of Critical Quality Attributes (CQAs) and associated analytical tools used during the development process and for successful launch.

By the end of this course, participants will have a solid understanding of the complexities involved during CMC and nonclinical development of RNA/DNA-based drugs incl. oligonucleotides covering requirements until regulatory marketing approval.
Your benefit

After participating in the webcast series you as scientists and professionals will be sensitized for the challenges to face during the development of RNA-based drugs and oligonucleotides. Our experts will demonstrate the aspects that are essential to consider, show the potential of the drug classes and help to overcome hurdles and to avoid common pitfalls.

Your benefits: Possibility to directly interact with the speaker; You will receive a certificate after each session; You are unable to attend one of the sessions? Benefit from the recording of each webcast!

Pharma seminar - The A-Z of RNA-based drugs and oligonucleotides

Technical CMC & Non-Clinical
Development of RNA/DNA-based drugs

- Webcast series -

Benefits
  • Tipps + tricks from renowned experts
  • The latest details
  • 5 webcasts à 2h: convenient to integrate into your work routine
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24092473

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

11/09/-11/12/2024

11/09/-11/12/2024

Zeitraum

11th, 18th, 25th September and 2nd, 10th October 2024
Live webcast from 02:00 pm - 04:00 pm
You may dial in 30 minutes before the training starts

11th, 18th, 25th September and 2nd, 10th October 2024
Live webcast from 02:00 pm - 04:00 pm
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

RNA-/DNA-based drugs: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.

Topics

  • Concept: Five weekly live webcasts à 2 hours with longtime experienced speakers
  • Topics covered: CMC and non-clinical aspects, challenges during technical drug development incl. analytical tools and formulation principles, regulatory requirements
  • Your benefits: Possibility to directly interact with the speaker; you will receive a certificate after each session; you are unable to attend one of the sessions? benefit from the recording of each webcast!


Who should attend
The target audience for this training comprises professionals in the pharma & healthcare sector as well as scientists from research institutes/universities who are involved in technical CMC or non-clinical development of RNA/DNA-based drugs incl. oligonucleotides.

Aims and objectives

You desire comprehensive knowledge and understanding of the key aspects involved in the technical CMC and non-cliinical development of RNA/DNA-based drugs incl. oligonucleotides also covering regulatory aspects?

The webcast series will delve into the principles and challenges encountered during the CMC and non-clinical drug development phase, including the formulation of these drugs. It will also cover the regulatory requirements that need to be met for the successful approval.
Furthermore, the course will introduce and explain the concept of Critical Quality Attributes (CQAs) and associated analytical tools used during the development process and for successful launch.

By the end of this course, participants will have a solid understanding of the complexities involved during CMC and nonclinical development of RNA/DNA-based drugs incl. oligonucleotides covering requirements until regulatory marketing approval.

Your benefit

After participating in the webcast series you as scientists and professionals will be sensitized for the challenges to face during the development of RNA-based drugs and oligonucleotides. Our experts will demonstrate the aspects that are essential to consider, show the potential of the drug classes and help to overcome hurdles and to avoid common pitfalls.

Your benefits: Possibility to directly interact with the speaker; You will receive a certificate after each session; You are unable to attend one of the sessions? Benefit from the recording of each webcast!

Detailed programme

11th, 18th, 25th September and 2nd, 10th October 2024
Live webcast from 02:00 pm - 04:00 pm
You may dial in 30 minutes before the training starts

14:00 - 16:00

Dr Satish Singh

11 September 2024: General overview - principles and challenges during technical CMC development"
  • History
  • Mode of action/modalities
  • Classification
  • Design principles (drug substance)
  • Development and regulatory challenges

14:00 - 16:00

Dr Clara Ferloni

18 September 2024: Regulatory aspects of nucleic acid-based drugs
  • Regulatory environment: past, present & future
  • Regulation of nucleic acis-based drugs and their manufacturers
  • The regulatory lifecycle from clinical trials to market approval

14:00 - 16:00

Dr Anika Schröter

25 September 2024: Non-clinical aspects of nucleic acid-based drug development
  • Classification of nucleic acid-based drugs and impact on non-clinical program
  • "Standard" non-clinical programs for different nucleic acid-based drugs, focused on safety evaluation
  • Class-specific considerations: known risks
  • Examples

14:00 - 16:00

Dr Maria Schwarz and Dr Andrei Hutanu

2 October 2024: CQAs and analytical tools
  • Overview of molecular features of nucleic acid DS and DP
  • Available analytical tools/strategies and their applicability
  • From physico-/biochemical features to the analytical assessment of the CQA
  • Characterisation and stability of nucleic acid formulations

14:00 - 16:00

Dr Andrea Allmendinger and Dr Michal M. Raczy

10 October 2024: Formulation and drug product process development of nucleic acid-based therapeutics
  • Definition drug substance (DS) and drug product (DP)
  • Overview of commercial formulations
  • Formulation strategies, stability/stress studies and related CQAs
  • Excipient selection for parenteral products, raw material control
  • Selection of dosage form and container closure system
  • Entry-into-human enabling studies
  • Process development: CPPs, clinical phase-appropriate approach, challenges in sterile manufacturing

Our partners

Solvias AG

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the pharmaceutical and biotech industry. Its team of scientists combine years of experience with regulatory understanding across small molecules, biologics, and cell and gene therapies. The company offers comprehensive solutions from raw materials to drug products to final release testing, as well as API development and manufacturing for small molecules. Headquartered near Basel, Switzerland, Solvias operates five facilities to the highest standards and in accordance with ISO, GMP, GLP and FDA regulations. For more information, visit solvias.com.



ten23 health AG

ten23 health®, based in Basel and Visp, Switzerland, is the strategic, sustainable partner of choice for the pharmaceutical industry and biotech start-ups that puts people at the centre: We develop, produce and test cutting-edge medicines. We support our clients in developing differentiated, stable, applicable and safe injectable treatment options for patients. ten23 health® combines the latest scientific knowledge with proven and tested world-class industry and regulatory expertise to break new ground for our clients. We deliver our innovative services in a fair and sustainable way, respecting the health of people and the future of our planet.





Dr. Anika Schroeter e.U.

Anika Schröter is a non-clinical and toxicology consultant with 10 years of experience in the field of drug development. In 2021, she founded her own company in Vienna (Dr. Anika Schroeter e.U.) offering consultancy services around the non-clinical development of biologicals and small molecules with specific focus on regulatory-compliant toxicology testing. Anika Schröter is certified as European Registered Toxicologist (ERT) and holds a Diploma degree in the field of biology from the University in Dresden (Germany) and a PhD (Dr. rer. nat.) in the field of biology / toxicology from the University of Vienna (Austria). In addition, Anika is working as a lecturer in advanced education courses providing insights into specifics of non-clinical drug development.



More information

In-house seminars: Training that fits!

Are you looking for this topic for several employees?
We offer the right solution at your premises or in virtual format!
We also offer this seminar as an in-house seminar.


Take advantage of the tried-and-tested concepts of our open seminars and bring your employees together quickly and easily to the same level of knowledge.
We will be happy to send you a non-binding offer.

Benefits of a FORUM Institut training course

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.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

Recommendations

GDP-Verträge

Sie sind Nicht-Jurist und an der Erstellung von GDP-Verträgen beteiligt? Dann ist dieses Online-Seminar für Praktiker wi...

08.10.2024, Online
Details

All about ATMP

Das Online-Seminar zu den Themen Entwicklung, Qualität, CMC, Zulassung und Market Access für ATMPs.

26. - 27.09.2024, Online
Details

Arzneimittelzulassung für Einsteiger

In diesem Seminar erhalten Sie Know-how zur Zulassung von Arzneimitteln in Europa. Sie lernen, welche Zulassungswege mög...

27. - 30.08.2024, Online
Details

MASTER CLASS Großhandelsbeauftragte

DAS virtuelle Spezialseminar zu weitergehenden Verantwortlichkeiten und Pflichten von Großhandelsbeauftragten!

29.08.2024, Online
Details

Grenzen der Medizinprodukte-Werbung

Das Bewerben von Medizinprodukten ist essenziell, um das eigene Produkt im Markt zu etablieren. In der Praxis besteht di...

10.07.2024, Online
Details

Go forward

DEMO-Account e-Learning

Try out our e-Learning programmes free of charge and without any obligation.

Details
DEMO-Account e-Learning
White paper: "Non-clinical aspects of RNA-based drug development"

The development of RNA-based drugs has increased within the past years and is a promising field of research in the pharm...

Details
White paper:
Our rating in 2023

More than 4,500 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.

Details
Our rating in 2023