FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505

QbD elements in early and late stage biotherapeutic development
(from research to first in human until commercial)

Live webcast on 27 November 2018, 14.00 (CET)

Implementation of QbD elements:
  • Quality attributes / critical quality attributes
  • Quality target product profile (QTPP)
  • Comparability studies



Dr Dorothee Ambrosius
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
 
Head of CMC Strategy Biologicals

Quality of Biotech-IMPs – the current challenges 

Live webcast on 11 December 2018, 14.00 (CET)

  • Impact of the current voluntary harmonisation procedure (VHP) and the new clinical trial regulation on pharmaceutical quality
  • Current and future regulatory -scientific requirements and challenges with regards to quality and its documentation

 

Dr Jörg Engelbergs
Paul-Ehrlich-Institut (PEI), Langen
 
Scientific Expert (CMC/Non-Clinic) for Monoclonal Antibody Therapeutics

Analytical development concepts to guide CMC development 

Live webcast on 22 January 2019, 14.00 (CET)

  • Current analytical methods
  • Specification and validation
  • Developmental vs. CMC data



- requested -
Dr René Thürmer
Expert for pharmaceutical Quality, Bonn

Cell line development 

Live webcast on 13 February 2019, 14.00 (CET)

  • Host cells
  • State-of-the-art cell line generation process
  • Importance of monoclonality assurance
  • Bioreactor assessment
  • Phenotypic & genotypic stability

 

Dr Simon Fischer / Dr Barbara Enenkel
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach

Head of Cell Line Development CMB / Senior Associate Director Bioprocess and Analytical Development

Virus safety 

Live webcast 13 March 2019, 14.00 (CET)

  • Potential sources of virus contamination
  • Cell line qualification: testing for viruses
  • Testing for viruses in unprocessed bulk
  • Virus validation studies



Dr Sabine Häcker / Dr Barbara Enenkel
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach

Head Virus Test / Senior Associate Director Bioprocess and Analytical Development

Upstream development (early and late stage) 

Live webcast on 9 April 2019, 14.00 (CET)

  • Process characterisation
  • Fermentation development
  • Scale-up and scale-down approaches

 

Dr Markus Michael Müller
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
 
Associate Director of Cell Culture Development CMB

Downstream development (late stage) 

Live webcast on 14 Mai 2019, 14.00 (CET)

  • Late stage development
  • Stage I validation



Jessica Stolzenberger
Boehringer Ingelheim Pharma GmbH & Co. KG,
 
Head of Laboratory, Late Stage DSP Development

Pharmaceutical Development of Biologics Drug Products: the interface of formulation, primary packaging and application

Live webcast on 4 June 2019, 14.00 (CET)

  • Protein stability challenges and ways to address by formulation
  • Special topic : particles, particles everywhere
  • Special topic : surfactants – the good, the bad and the ugly
  • Container closure system compatibility
  • Challenges in the development and application of highly concentrated formulations
  • Challenges in the application of low clinical doses



Dr Susanne Jörg
Lonza AG
 
Head of Formulation Development, Drug Product Services

Bioassays 

Live webcast on 2 July 2019, 14.00 (CET)

  • why are they needed?
  • advantages/disadvantages of bioassay setups
  • replacement of bioassays



- requested -
Dr Katrin Buss

Expert for pharmaceutical Quality and Regulatory Affairs, Bonn

Stability concept: pre and post launch 

Live webcast 28 August 2019, 14.00 (CET)

  • Stability programmes
  • Use of bracketing/matrixing
  • Extrapolation of the shelf life
  • Stress stability studies
  • Stability indicating methods
  • Container closure integrity testing



Dr Rainer Ilg
Boehringer Ingelheim Pharma GmbH & Co. KG
 
Senior Associate Director, Global Technical Regulatory Affairs

Comparability – Similarity assessment 

Live webcast on 17 September 2019, 14.00 (CET)

  • Differences and common features
  • Assessment of critical quality attributes
  • Demonstration of analytical comparability
  • during development
  • during changes in the manufacturing process
  • tech transfer and challenges
  • Demonstration of analytical similarity
  • Different approaches to show similarity in US and EU
  • Justification of differences



Dr Manuel Wittner, Associate Director, Global Technical Regulatory Affairs




Dr Beatrix Metzner, Head of Global Technical Regulatory Affairs

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach

CMC Life Cycle Management: ICH Q12 and others 

Live webcast on 15 October 2019, 14.00 (CET)

  • Post-approval change management protocol (PCMP)
  • How to achieve regulatory flexibility?
  • Requirements regarding tech transfer

 Dr Steffen Groß

Paul-Ehrlich-Institut (PEI), Langen
 

'Data exclusivity: specific characteristics for biologics/biosimilars'

Live webcast on 27 November 2019, 14.00 (CET)

  • Post approval change management protocol (PCMP)
  • How to achieve regulatory flexibility?
  • Requirements regarding tech transfer

Prof. Burkhard Sträter

Partner, Sträter Lawyers, Bonn
Awards and cooperation partners