FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Phone: +49 6221 500-500
Fax: +49 6221 500-505

Interface Regulators - HTA Bodies, early parallel consultations for Regulatory Affairs together with Market Access

Live webcast on 16 Januar 2020, 14.00 (CET)

  • The current procedure for EMA: EUnetHTA parallel consultation
  • Parallel consultation briefing book: challenges and opportunities
  • Parallel consultation vs single national consultations: pros and cons
  • Overview upcoming EU-HTA

Dr. Maren von Fritschen, Managing Director, AddOn Pharma GmbH, Berlin
    Dr. Simone Breitkopf, CEO and Founder, MEDICAL CONSULTING, Berlin

Drug Device Combination Products for Biologicals

Live webcast on 29 January 2020, 14.00 (CET)

  • What is a medical device/combination product? non-regulatory viewpoint and regulatory requirements in US & EU
  • Crash course in design control Pharma companies often do not speak the language of 'drug-device combination product development'
  • Design verification and validation - The cornerstones of Design Control
  • Human Factors Engineering (HFE) A requirement to prevent 'hopelessly failed engineering' (HFE)
  • Risk Management according to ISO 14971 The basis for pretty much everything
  • Drug Device Combination Products for Biologics Requirements and Examples

Dr. Steffen Schuy

Combination Product & Process Development Manager, Pharmaceutical Dev. Biologicals, Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim


Live webcast on 4 February 2020, 14.00 (CET)

  • Why are therapeutic proteins immunogenic?
  • Why is testing of immunogenicity required?
  • How to test immunogenicity?
  • Immunogenicity Risk Assessment
  • How to predict immunogenicity
  • How to mitigate immunogenicity

 Dr. Daniel Kramer

Global Scientific Advisor Immunogenicity, Sanofi-Aventis Deutschland GmbH, Frankfurt

Quality part of the IMPD and IND for biologics and ATMPs

Live webcast on 3 March 2020, 14.00 (CET)

  • The GTMP regulatory landscape
  • IMPD structure and key sections for GTMPs
  • Data requirements for manufacture and control
  • Gene therapy product class specificities
  • Extent of data with respect to clinical development

 Dr. Matthias Renner

Assessor of Gene Transfer Medicinal Products, Paul-Ehrlich-Institut (PEI),

Biosimilar Development

Live webcast on 29 April 2020, 14.00 (CET)

  • Regulatory requirements
  • Development strategies, change over time
  • Clinical development strategies

 Dr. Karsten Roth

Director Clinical Research and Development, Polpharma Biologics S.A.,
Warsaw, Poland

Preclinical and clinical R&D: present and future

Live webcast on 14 May 2020, 14.00 (CET)

  • Preclinical: pharmacology, toxicology and pharmacokinetics of biologics
  • First-in-human trials
  • Safety and efficacy in patients: clinical development and drug safety
  • Analytics in preclinical and clinical settings

 Dr. Matthias Germer

Vice President Preclinical Research, Biotest AG, Dreieich

ATMP and specifically gene therapy: CMC challenges for development and registration

Live webcast on 22 June 2020, 14.00 (CET)

  • The product classes of ATMPs
  • Starting materials, their suitability and their control
  • Definition of drug substance and drug product
  • Control strategies for ATMPs
  • Comparability after process changes

 Dr. Robert E. Zoubek

Senior Consultant, Granzer Regulatory Consulting & Services, Munich

CMC requirements ATMPs: interface Production & RA

Live webcast on 9 July 2020, 14.00 (CET)

  • Brief summary of legal and regulatory requirements and procedures for ATMPs in the EU and USA
  • CMC for ATMPs: different product types and requirements from early development to marketing
  • Common pitfalls and specific examples of key regulatory issues for CMC of ATMPs
  • Issues and potential strategies for integrating regulatory affairs into CMC development for ATMPs and product lifecycle

 Dr. Christopher Mann

Scientific & Regulatory Affairs Associate Director, ASPHALION S.L., Barcelona

Extractables and leachables: regulatory expectations to laboratory studies

Live webcast on 22 July 2020, 14.00 (CET)

  • Contact of (bio-)pharmaceutical formulations with manufacturing, storage and administration materials leads to contamination with leachables
  • Leaching has to be controlled and minimized to ensure patients’ safety
  • A proper control strategy in the form of an extractables/leachables (EL) assessment is described
  • The assessment includes material risk evaluation, quantitative EL laboratory studies on high risk materials and toxicological evaluation of EL compounds exceeding safety thresholds

 Dr. Michael Jahn

Head Forensic Chemistry, Lonza AG, Drug Product Services, Basel, Switzerland

Biosimilar development: quality and non-clinical parts

Live webcast on 29 September 2020, 14.00 (CET)

  • What regulators expect
  • Statistical approaches
  • New regulatory developments

 Dr. Nils Jost

Assessor Non-Clinic and Quality, Paul-Ehrlich-Institut (PEI), Langen

Future digitalisation trends in submission and labelling

Live webcast on 23 October 2020, 14.00 (CET)

  • eSubmission Update
  • eSubmission standards in the EU; further harmonization at ICH level?
  • Electronic product information (ePI) in the EU: status of current EMA action plan
  • Update and maintenance of ePI: anticipated improvement of the labelling process

 Dr. Peter Bachmann

Senior Expert Regulatory Affairs, Bonn

Topic to be announced

Live webcast on 12 November 2020, 14.00 (CET)

 Dr. Bernd Liedert

Expert for Clinical Development of New Biologic Entities and Biosimilars, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim

ICH Q14 und revision ICH Q2

Live webcast on 3 December 2020, 14.00 (CET)

  • ICH Q14: a new Quality Guideline on Analytical Procedure Development
  • ICH Q2(R1): revision of the Guideline on Validation of Analytical Procedures
  • Harmonisation of the scientific approaches of analytical procedure development
  • Provision of the principles relating to the description of the analytical procedure development process

 Dr. René Thürmer

Expert for Pharmaceutical Quality, Bonn
Awards and cooperation partners


Dr Birgit Wessels

Conference Manager Pharma & Healthcare

+49 6221 500-652