PharmaFORUM Webcast Biologics

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

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Programm 2023

Regulatory requirements for combinations of drugs and devices
  • Legal framework
  • Types of combinations of drugs and devices
  • Requirements for the quality documentation in the CTD
  • Case studies







12 January 2023, 10:00 CET
Dr Katrin Buss
MINISTERIAL DECISION ON THE TRIPS AGREEMENT relating to the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines (June 2022)
  • What is a patent waiver on COVID-19 vaccines?
  • How is it implemented in the WTO Agreement on Trade-Related Aspects of IP Rights (TRIPS)?
  • What are the consequences?


23 February 2023, 14:00 CET
Jürgen Schneider
Human antibodies – Case studies: What kind of supporting (non-)clinical data is required for CMC changes to
  • manufacturing and testing sites
  • cell banks
  • the manufacturing process
  • analytical methods and specifications
  • the drug product formulation and/or presentation
  • the delivery device (in case of integral drug-device combinations)?
21 March 2023, 14:00 CET
Dr Sonja Matt
Questions at the interface of CMC and non-clinics: How to contribute to successful non-clinical drug development

  • “The product is the process”: characterization of the product and its impact on non-clinical drug development
  • Test item requirements for non-clinical studies
  • Formulation analytics for GLP studies

  

25 April 2023, 14:00 CET
Dr Alexandra Günzl 
First-in-human (FIH) clinical trial applications and INDs for ATMPs: special considerations

  • Structure and timing of the application(s): tricks and tips to simplify
  • Interface between the IB and other parts of the dossier and what to include and what not to include
  • Special documents, such as pharmacy Manual, Surgery Manual
  • Special considerations, such as HTA involvement, GMO licenses, potency assays, long-term follow-up (LTFU)  
17 May 2023, 14:00 CET
Dr. Christopher Mann
Filing for a BLA vs MAA application with focus on the CMC requirements
  • Regulatory landscape: Authorities and regulations
  • Specific CMC requirements: Documentation to be included in the global dossier (comparison BLA vs. MAA)
  • Practical experiences from industry perspective (e. g. Transfer Topics)
  • the delivery device (in case of integral drug-device combinations)?

 

 


15 June 2023, 14:00 CET
Dr Christina Juli
Marketing Authorisation in Brazil with a focus on CMC
  • General requirements and additional quality data to be generated
  • Documentation to be included in the dossier in context of CTA, MAA/BLA and post-approval changes
  • Practical experiences from industry perspective





 

 

 

 
10 August 2023, 14:00 CET
Ana Terra Dos Santos Macedo
The new Clinical Trial Regulation and the Go-Live of Clinical Trial Information System (CTIS)
  • Challenges & learning curve from the past 1,5 years
  • Experiences from industry perspective: Special use cases & practical examples
    • Managing Quality IMPD & sIMPD
    • Differentiation of public/restricted area
    • How to deal with response to HA questions
  • How industry could leverage from the usage of CTIS

19 September 2023, 14:00 CET
Katharina Mayer
Advantages and disadvantages of different approval procedures (MRP/DCP/CP)
  • How the different procedures work: Timelines and specificities
  • Aspects to consider on choosing the best authorisation procedure for your product
  • Efficiently preparing the procedure
 
 
12 October 2023, 14:00 CET
Dr Andreas Bonertz
Hospital exemption in the initial application and regulatory context
  • What is the EU Commission planning?
  • Procedure for obtaining a hospital exemption in Germany
  • Hospital exemption in the German reimbursement complex

 

9 November 2023, 14:00 CET
Dr Alexander Natz
CMC requirements for Gene Therapy Medicinal Products: US and EU jurisdiction
  • Vector design
  • Ex-vivo/in-vivo gene therapy
  • Genome editing
  • Drug substance and product manufacture
  • Safety testing, adventitious agents

 

 

14 December 2023, 14:00 CET
Dr Ralf Hess

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The  current challenges in analytics, development, quality and regulatory affairs (pre- and post-authorisation phases) of biologics

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Your contact person

Dr Birgit Wessels
Conference Manager
Pharmaceuticals & Healthcare
Phone: (+49) 62 21 / 500 652
E-Mail: [email protected]

Prices & Membership

Membership of the PharmaFORUM Webcast Biologics is available for one year. The annual membership fee of €1800 (plus German VAT) is due upon registration. Membership is automatically extended by a further year unless written notice has been submitted no later than six weeks before the end of the membership. Membership for 12 months may be started at any time.

Find out more in our information brochure

information brochure

Who should attend?

This webcast series addresses the needs of managers in the biopharmaceutical industry needing to keep up to date with development, quality, analytics and regulatory affairs, in particular with CMC related topics.

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