PharmaFORUM Webcast Biologics 2021 - FORUM Institut
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WEBCAST SERIES PharmaFORUM Webcast Biologics 2021 Development, Quality and Regulatory Affairs THE UPCOMING WEBCASTS AT A GL ANCE • Covid-19: Integration and acceleration in medical science • Recent regulatory developments concerning manufacturing and control of ATMPs • Requirements for biologicals in the IMPD • Use of big data and real world evidence for regulatory purposes • CMC requirements for new excipients focus Biologics • ICH Q12 – Current status YOUR BENEFITS • One live webcast with international experts every month • Consolidated information in a short period of time at your work place • Possibility to directly interact with the speaker w w w.forum -institut .com/pharma -webcast-biologics
PharmaFORUM Webcast Biologics 2021
Concept Additional useful information
Do you work with biologics? Then, we would Are you unable to attend one of the web-
like to invite you to join our live webcasts casts? No problem! Following each live mee-
every month. ting, you will be able to retrieve the recorded
Our experts will provide you with the latest webcast from our e-learning centre using
information on the current challenges in your personal password. This allows you to
analytics, development, quality and regu- review each webcast at any time and as of-
latory affairs (pre- and post-authorisation ten as you like. An optional multiple choice
phases) of biologics. Most webcasts are test finalizes each webcast, giving you the
specifically focused on CMC while addres- possibility to receive a personal certificate.
sing topics at the interface quality and Get a first impression at
regulatory affairs. www.forum-institut.com/pharma-webcast-
You will meet our experts in a virtual confe- biologics
rence room and share your experiences live.
Each meeting will be held as a 1.5 to 2-hour
webcast, presenting the latest news with
Technical requirements
supporting presentation slides. To be best
prepared, you will be able to download the In order to join in our live webcast, you will
complete presentation documents prior to need a standard PC with a current browser,
each webcast. a soundcard, speakers or a headset, and a
reliable Internet connection. You may choose
between calling via telephone and calling via
computer (VoIP) for audio connectivity.
Your benefits
• Twelve live webcasts with international
experts per year
• Recorded webcasts at our learning
centre to review as often as you like
• Documentation for your download
• Multiple choice test after each webcast
to obtain a personal certificateProgramme, dates and exper ts
Star ts
at
14:00 C
ET
Your Programme Date Your E xper t
IDMP and SPOR – Future EMA use cases 21 January 2021 Christine Hirt
• Status EU Implementation Guide
• How can companies prepare?
• How can RIMS help?
Covid-19: Integration and acceleration 9 February 2021 Dr Matthias Germer
in medical science
• Adaption of regulatory requirements under
Covid-19 pandemic
• The fast track of diagnostic and therapeutic
innovations
• Importance of agile techniques for drug
development
• New business models and alliances between
the industry, authorities, foundations, etc.
• The change in relation of stakeholders
Topic to be announced 25 March 2021 TBA
Specific regulatory aspects and interaction 27 April 2021 Wiebke Hoppensack,
with regulators in the development and Dr Bettina Kartmann
authorisation process
• Use of scientific advice choises (EU/national),
e.g. EU SA process, PEI-specific consulting
formats
• PRIME: Concept, eligibility request procedures,
interactions with PRIME Rapp
• Module 3 - Specific requirements for biologics
(What‘s dossier-/GMP-relevant?)
• Specific regulatory aspects: Choice of
legal basis, duplicates, current Hot Topics
Recent regulatory developments concerning 18 May 2021 Dr Matthias Renner
manufacturing and control of ATMPs
• Discussion of novel and revised guidelines
• Update on activities fostering ATMP development
• The stakeholder-agency interactionProgramme, dates and exper ts Your Programme Date Your E xper t Requirements for biologicals in the IMPD 8 June 2021 Dr Katrin Buss • IMPD structure - requested - • General considerations regarding differences between IMPD and CTD • Phase based approach • Strategies to reduce (substantial) amendments Establishing a starting dose for a first-in-human 6 July 2021 Dr Anika Schröter/ clinical trial: A challenge for gene/cell therapies Dr Monika Chabicovsky • Overview of regulatory expectations • Conventional vs. innovative approaches • Product-specific examples AT(I)MPs in development: Challenges for QA/QC 31 August 2021 Dr Ralph Nussbaum Use of big data and real world evidence for 7 September 2021 Dr Ulrich Granzer regulatory purposes • EU: EMA and HMA task force • FDA Sentinel Approach • First experiences, examples CMC requirements for new excipients 19 October 2021 Dr Heike Volkmer • Different requirements: US vs. EU submission • How do regulatory requirements impact the development of new excipients? • Which data package will be needed? • How to avoid delays in formulation development using new excipients? • Do’s and dont´s for new excipients in the development of new biologics ICH Q12 – Current status 16 November 2021 Dr Steffen Groß Go West – The IND for Biologics 14 December 2021 Dr Tobias Zahn • Requirements for a clinical trial in the US • How does an IND differ from an IMPD/CTA in Europe? • Corporate strategy considerations
Your exper ts
Christine Hirt Dr Monika Chabicovsky
MAIN5 GmbH & Co. KGaA, MC Toxicology Consulting GmbH,
Frankfurt, Germany Wien, Austria
Management Consultant Managing Director
Dr Matthias Germer Dr Ralph Nussbaum
Biotest AG, Auregen BioTherapeutics GmbH,
Dreieich, Germany Reutlingen, Germany
Vice President Preclinical Vice President Quality
Research Management
Wiebke Hoppensack Dr Ulrich Granzer
Paul-Ehrlich-Institut (PEI), Granzer Regulatory
Langen, Germany Consulting & Services
München, Germany
Scientific Officer
Geschäftsführer
Dr Bettina Kartmann
Paul-Ehrlich-Institut (PEI), Dr Heike Volkmer
Langen, Germany VBC Team GmbH,
Hannover, Germany
Scientific Officer
Managing Director und
Dr Matthias Renner Principle Consultant
Paul-Ehrlich-Institut (PEI),
Langen, Germany Dr Steffen Groß
Assessor of Gene Transfer Paul-Ehrlich-Institut (PEI),
Medicinal Products Langen, Germany
Laboratory Head and
Dr Katrin Buss Scientific Assessor
- requested -
Bonn, Germany Dr Tobias Zahn
Assessor für 3R Pharma Consulting GmbH,
Pharmazeutische Qualität Dobel, Germany
Consultant for
Dr Anika Schröter Drug Development
MC Toxicology Consulting GmbH,
Wien, Austria
Consultant Non-Clinical
DevelopmentPharmaFORUM Webcast Biologics 2021
HOW TO REGISTER
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www.forum-institut.de Fax +49 6221 500-555
www.forum-institut.com/pharma-webcast-biologics
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Benefits
Company • Twelve live webcasts per year
• Recorded presentations since 2018 available
at our e-learning centre
Street
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• Multiple choice test and personal certificate
Post code, city, country after each webcast
Tel. no./Fax no. Please try us out! Get your free demo account and
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CANCELL ATION POLICY YOUR CONTACT
Our general terms and conditions (as of1 January
2016) apply and are available upon request.We can Dr Birgit Wessels
send them to you at any time. Alternatively, you can Conference Manager
access them online at www.forum-institut.com/t&c Pharmaceuticals & Healthcare
Tel. +49 6221 500-652
b.wessels@forum-institut.de
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