2024-06-20 2024-06-20 , online online, 1,190 € zzgl. MwSt. Dr. Jörg Engelbergs https://forum-institut.de/seminar/24062472-biopharmaceuticals/referenten/24/24_06/24062472-online-course-pharma-biopharmaceuticalsbiotech-drugs_engelbergs-joerg.jpg Biopharmaceuticals

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.190€ plus VAT) - for booking, please contact us!

Topics
    Development & manufacturing on 24 June 2024:
  • Manufacturing process
  • Formulation
  • Process changes
  • Regulatotory requirements on 25 June 2024:
  • IMPD quality part
  • Non clinical aspects
  • Regulatory update: Biologics und biosimilars
  • Biopharmaceutical analytics on 26 June 2024:
  • Method validation
  • Stability testing
  • Specifications


Who should attend
This course is aimed at specialists and managers in the pharmaceutical industry who are involved in the development, production and analysis of biotechnological drugs.

The focus on all three days will be on familiarising you with the regulatory framework with reference to guidelines.

In particular, employees in the departments of research & development, regulatory affairs, manufacturing, analytics, quality assurance and quality control will benefit from attending.
Aims and objectives
After Day 1, you will be familiar with the specialties of galenic development process technologies and you will know what to look out for in process changes and comparability studies.

After day 2, you will be aware of critical quality parameters of biologics and biosimilars and know the challenges of the non-clinical program.

After day 3, you will have gained expertise in method validation, stability testing and specification writing.

Following Day 3, you will receive the access data for the optional online test for learning success control by e-mail.
Your benefit

  • You know the current regulatory requirements for the (non-)clinical development of biologics and biosimilars
  • You know critical quality parameters of biopharmaceuticals
  • You know which data are required for the IMPD compilation and the quality documentation
  • You know specifics of proteins and what challenges to overcome in formulation development
  • You know which requirements exist for the manufacturing process of active ingredients and finished medicinal products - from clinical development to marketing authorisation - and you are familiar with the corresponding process technologies
  • You can implement comparability requirements in case of changes
  • You will be able to implement regulatory requirements for analytics, including method development/validation and setting and justifying specifications
  • You know the requirements for stability testing according to ICH and for method validation according to FDA

Online course pharma - Biopharmaceuticals/biotech drugs

Biopharmaceuticals:
Development, manufacturing
and analytics

- Online training -

Benefits
  • Excellent speakers
  • Different perspectives
  • Knowledge transfer at the highest level
  • All course days can be booked individually, contact us!
  • Officially certified according to ISO 9001 + 21001

Webcode 24062472

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

24-26/06/2024

24-26/06/2024

Zeitraum

Day I-IIII: 09:00 am - 5:00 pm - Online training
You may dial in 30 minutes before the training starts

Day I-IIII: 09:00 am - 5:00 pm - Online training
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

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.190€ plus VAT) - for booking, please contact us!

Topics

    Development & manufacturing on 24 June 2024:
  • Manufacturing process
  • Formulation
  • Process changes
  • Regulatotory requirements on 25 June 2024:
  • IMPD quality part
  • Non clinical aspects
  • Regulatory update: Biologics und biosimilars
  • Biopharmaceutical analytics on 26 June 2024:
  • Method validation
  • Stability testing
  • Specifications


Who should attend
This course is aimed at specialists and managers in the pharmaceutical industry who are involved in the development, production and analysis of biotechnological drugs.

The focus on all three days will be on familiarising you with the regulatory framework with reference to guidelines.

In particular, employees in the departments of research & development, regulatory affairs, manufacturing, analytics, quality assurance and quality control will benefit from attending.

Aims and objectives

After Day 1, you will be familiar with the specialties of galenic development process technologies and you will know what to look out for in process changes and comparability studies.

After day 2, you will be aware of critical quality parameters of biologics and biosimilars and know the challenges of the non-clinical program.

After day 3, you will have gained expertise in method validation, stability testing and specification writing.

Following Day 3, you will receive the access data for the optional online test for learning success control by e-mail.

Your benefit

  • You know the current regulatory requirements for the (non-)clinical development of biologics and biosimilars
  • You know critical quality parameters of biopharmaceuticals
  • You know which data are required for the IMPD compilation and the quality documentation
  • You know specifics of proteins and what challenges to overcome in formulation development
  • You know which requirements exist for the manufacturing process of active ingredients and finished medicinal products - from clinical development to marketing authorisation - and you are familiar with the corresponding process technologies
  • You can implement comparability requirements in case of changes
  • You will be able to implement regulatory requirements for analytics, including method development/validation and setting and justifying specifications
  • You know the requirements for stability testing according to ICH and for method validation according to FDA

Detailed programme

Day I-IIII: 09:00 am - 5:00 pm - Online training
You may dial in 30 minutes before the training starts

09:00

Dr Josef Gabelsberger

Manufacturing process of the protein active ingredient
  • Production systems: Requirements
  • Practical challenges in development and manufacturing

10:30 Coffee break


11:00

Dr Monika Geiger

From active substance to protein formulation
  • Peculiarities of proteins
  • Formulation development
  • Analytics for formulation development
  • Requirements for primary packaging materials

12:30 Lunch break


13:30

Dr. Jörg Engelbergs

Active ingredient/finished drug product manufacturing process (from clinical development to MA): Requirements
  • Active substance characterisation and impurity profiles
  • Definition of specifications and acceptance criteria

15:00 Coffee break


15:15

Dr Jörg Engelbergs

Comparability studies for manufacturing process changes
  • Demonstration of comparability during clinical development: requirements
  • Comparability exercise according to guideline ICH Q5E: Demonstration of comparability after approval
  • Ensuring regulatory compliance - change control: Variations & PACMPs

17:00 End of day 1


09:00

Dr Sonja Matt

Requirements for the IMPD quality part
  • Scope of the documentation
  • Status of process validation and analytical methods
  • Stability of IMP
  • Approaches for CTA (history and future)

11:00

Dr Anika Schröter

Biologics: Non-clinical aspects I
  • Standard requirements and deviation from the standard ("case-by-case").
  • Considerations for the determination of the starting dose in humans

12:00 Lunch break


13:00

Dr Anika Schröter

Biologics: Non-clinical aspects II

14:00

Dr Sonja Matt

Update on regulatory landscape I
  • Requirements for the evaluation of biosimilars
  • Definition of the similarity rank
  • Dealing with/and (non-)acceptance of differences

14:45 Coffee break


15:00

Dr. Anika Schröter

Biosimilars: Non-clinical aspects
  • Regulatory requirements

15:30

Dr Sonja Matt

Update on regulatory landscape II
  • Process validation: Innovations
  • Product and process development: QbD
  • Immunogenicity: Assessment
  • ICH Q12 & post approval change management protocol (PACMP)

17:00 End of day 2


09:00

Dr Matthias Germer

Analytics for clinical IMPs

10:15 Coffee break


10:30

Dr René Thürmer

Development and validation of analytical methods: Requirements for the registration dossier
  • Validation of protein analytical methods
  • Qualification of impurities in active ingredients and finished products
  • Typical dossier deficiencies

12:00 Lunch break


13:00

Dr Matthias Germer

Stability studies
  • Target setting; requirements for formal stability testing according to ICH

14:00

Dr René Thürmer

Update on ICH Q14: Development of analytical methods

14:45 Coffee break


15:00

Dr René Thürmer

Setting, justifying and changing specifications
  • Implementation of the ICH Q6B Guideline
  • Critical quality attributes, common errors and defects - case studies
  • Contamination specifications of drug substance and drug product
  • Regulations/responsibilities in the context of clinical studies/registration

16:30 Q&A day 3


17:00 End of Online Training


More information

Booking of individual course days

All three course days can be booked individually (a single day of your choice = €1,190 plus VAT).

For booking, please contact us!

Optional online test/learning success control

This course has been audited and accredited by the independent PharmaTrain Federation (www.pharmatrain.eu).
In this context, one pillar is the achievement of sustainable learning success.

For this reason, we offer you the opportunity to take an optional online multiple-choice test if you book all three days of the course.
This can be completed online up to 14 days after the event in order to document the knowledge acquired with a special certificate.
Completing the online test is optional. You will receive a certificate of attendance regardless of this.

Modular qualification programme for Development Expert Biologics

This seminar is the basic module of our Development Expert Biologics qualification programme.

The course concept:

  • You attend our basic course "Biopharmaceuticals"
Afterwards you will take part in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
You will receive structured further training and comprehensive knowledge on topics relating to the development and production of biologics
  • You can specialise according to your main area of activity through the targeted selection of seminars

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

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Testimonials

Teilnehmerstimmen aus Februar 2016
Sehr viele interessante und relevante Vorträge für meine tägliche Arbeit, gute Themenauswahl - rundum Übersicht; sehr gute Organisation, praktischer Nutzen, sehr gute Vortragende, gute Aufteilung; Möglichkeit der Zwischenfragen und hilfreiche Beantwortung; kompetente Referenten, Vielfalt von Themen


Sehr gute und detaillierte Präsentationen zu aktuellen Themen, die fachliche Diskussion mit den Dozenten; Ich würde jederzeit diese Veranstaltung weiter empfehlen

Dr. Christin Selent-Stier


Kleine Gruppengröße, dadurch gute Netzwerkmöglichkeiten, sehr gute Abdeckung des breiten Fachgebiets durch ausgewählte Themen; Als Lehrgang für Start-ups die sich mit der frühen klinischen Entwicklung von Biologicals befassen, sehr empfehlenswert!

Dr. Michaela Arndt

NCT Nationales Zentrum für Tumorerkrankungen

Teilnehmerstimmen aus Februar 2017
Vermittelt sehr gut die Säulen von der Entwicklung bis zum Markt

Florian Waldmann

Senior Manager Quality Control, Formycon AG


Empfehlenswert für Biosimilar CMC

Dr. Christian Panke

Projektmanager, Alvotech Germany GmbH