2026-05-27 2026-05-27 , online online, 1,290 € zzgl. MwSt. Fernando Blanco Rodríguez https://forum-institut.de/seminar/26112455-radiopharmaceuticals-a-practical-cmc-and-quality-perspective/referenten/26/26_11/26112455-pharma-seminar-radiopharmaceuticals-a-practical-cmc-quality_blanco-rodrguez-fernando.jpg Radiopharmaceuticals: A practical CMC and quality perspective

Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date guidance on CMC and quality requirements under current and forthcoming EU standards.

Topics
  • The new EMA quality guideline: Structure and core requirements
  • CDMO (Contract Development and Manufacturing Organisation) contribution to CMC strategy and regulatory dossier integration
  • The sponsors perspective: Owning CMC strategy across the lifecycle


Who should attend
This seminar is designed for regulatory affairs specialists and CMC managers working with radiopharmaceuticals in pharmaceutical companies, hospital pharmacies, CDMOs, or regulatory authorities who need to navigate the current and upcoming EMA requirements with confidence.
Aims and objectives
Radiopharmaceuticals are subject to a rapidly evolving regulatory landscape. At its centre stands the ongoing revision of the EMA's core quality guideline. Beyond this revision, further legislative updates are on the horizon (e.g. revision of ICH M4Q, emerging EU additional quality master file system).

This seminar provides a practical, application-oriented overview of the current and forthcoming EU regulatory framework for radiopharmaceuticals, covering CMC and quality requirements. Bringing together regulatory authority, CDMO, and sponsor perspectives in one program, participants gain both a solid understanding of regulatory requirements and direct insight into how they translate into daily practice, also at the "interfaces".
With major regulatory revisions still in progress, early awareness is key, giving your company the opportunity to assess implications and start preparing in good time.

Please note that the content addressed on the EMA Guideline on Quality of Radiopharmaceuticals refers to the draft version of the guideline currently in place.
Your benefit

After attending this seminar, you will be able to:

  • Follow the ongoing revision of the EMA Guideline on Quality of Radiopharmaceuticals and assess its potential implications for your regulatory and CMC work.
  • Apply current CMC requirements specific to radiopharmaceuticals, including stability testing, specification setting, and correct integration into the CTD framework.
  • Prepare and manage marketing authorisation applications and CMC variations with confidence, avoiding common pitfalls in dossier preparation.
  • Understand the role of CDMOs and suppliers in radiopharmaceutical CMC strategy and integrate externally generated data compliantly into regulatory dossiers.
  • Apply a sponsor-led perspective on CMC lifecycle management, from clinical development through to post-approval variations.

Pharma seminar - Radiopharmaceuticals: A practical CMC + quality

Radiopharmaceuticals: A practical CMC and quality perspective

Navigating current and future EMA requirements/EU regulatory standards

Benefits
  • Three expert perspectives: Authority, CDMO, sponsor
  • Hands-on dossier guidance , incl. lifecycle
  • Ahead of regulatory change
  • Future-proof your strategy
  • Officially certified: ISO 9001 + 21001

Webcode 26112455

Jetzt buchen

JETZT Buchen
Referenten

Fernando Blanco Rodríguez

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, SPAIN

Chemical and Pharmaceutical Division

Dr Natalia Ladygina

Trasis, Ans, BELGIUM

Regulatory Affairs CMC Expert Radiopharmaceuticals Natalia holds a background in biology with 10 years of research experience. She subsequently transitioned into regulatory affairs and has been working in the radiopharmaceutical industry for more than eight years.
More information please click here.

Steffi Wittmann

ITM Medical Isotopes GmbH, Garching, GERMANY

Senior Regulatory Affairs CMC Manager Steffi Wittmann is a pharmacist with over ten years of experience in the pharmaceutical industry, currently serving as Senior Regulatory Affairs CMC Manager at ITM Isotope Technologies Munich SE. She holds a degree in Pharmacy from the University of Leipzig.

Alles auf einen Blick

Termin

12/11/2026

12/11/2026

Zeitraum

from 9:00 am until 5:00 pm CET
You may dial in 30 minutes before the lecture starts

from 9:00 am until 5:00 pm CET
You may dial in 30 minutes before the lecture starts
Veranstaltungsort

online

online

Downloads
Abbreviation list_Drug Regulatory Affairs and CMC
Abbreviation list_Drug Regulatory Affairs and CMC
Gebühr

Event - 1,290€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.

Event - 1,290€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date guidance on CMC and quality requirements under current and forthcoming EU standards.

Topics

  • The new EMA quality guideline: Structure and core requirements
  • CDMO (Contract Development and Manufacturing Organisation) contribution to CMC strategy and regulatory dossier integration
  • The sponsors perspective: Owning CMC strategy across the lifecycle


Who should attend
This seminar is designed for regulatory affairs specialists and CMC managers working with radiopharmaceuticals in pharmaceutical companies, hospital pharmacies, CDMOs, or regulatory authorities who need to navigate the current and upcoming EMA requirements with confidence.

Aims and objectives

Radiopharmaceuticals are subject to a rapidly evolving regulatory landscape. At its centre stands the ongoing revision of the EMA's core quality guideline. Beyond this revision, further legislative updates are on the horizon (e.g. revision of ICH M4Q, emerging EU additional quality master file system).

This seminar provides a practical, application-oriented overview of the current and forthcoming EU regulatory framework for radiopharmaceuticals, covering CMC and quality requirements. Bringing together regulatory authority, CDMO, and sponsor perspectives in one program, participants gain both a solid understanding of regulatory requirements and direct insight into how they translate into daily practice, also at the "interfaces".
With major regulatory revisions still in progress, early awareness is key, giving your company the opportunity to assess implications and start preparing in good time.

Please note that the content addressed on the EMA Guideline on Quality of Radiopharmaceuticals refers to the draft version of the guideline currently in place.

Your benefit

After attending this seminar, you will be able to:

  • Follow the ongoing revision of the EMA Guideline on Quality of Radiopharmaceuticals and assess its potential implications for your regulatory and CMC work.
  • Apply current CMC requirements specific to radiopharmaceuticals, including stability testing, specification setting, and correct integration into the CTD framework.
  • Prepare and manage marketing authorisation applications and CMC variations with confidence, avoiding common pitfalls in dossier preparation.
  • Understand the role of CDMOs and suppliers in radiopharmaceutical CMC strategy and integrate externally generated data compliantly into regulatory dossiers.
  • Apply a sponsor-led perspective on CMC lifecycle management, from clinical development through to post-approval variations.

Detailed programme

from 9:00 am until 5:00 pm CET
You may dial in 30 minutes before the lecture starts

09:00 Welcome, introduction, expectations


09:15

Fernando Blanco Rodríguez

The new EMA quality guideline: Structure and core requirements (I)
  • The legal and regulatory framework for radiopharmaceuticals in the EU:Key changes in the revised pharmaceutical legislation related to radiopharmaceuticals?
    • Scientific Guidelines and
    • Texts of the Ph.Eur. specific for radiopharmaceuticals
  • Revision of Guideline on Radiopharmaceuticals: Background and objectives of the revision: What changes compared to Revision 1 (2008)? Integration into the CTD framework (module 3)
  • Active substance: contents of module 3.2.S for the different types of radiopharmaceuticals.
    • Radionuclide precursor (for ready for use radiopharmaceuticals, for radionuclide precursors or for radionuclide generators)
    • Active substance (for kits for radiopharmaceutical preparation) and chemical precursor (for ready-for-use radiopharmaceuticals)
    • Radiolabelled active substance (for ready for use radiopharmaceuticals)

10:45 Biobreak


11:00

Fernando Blanco Rodríguez

The new EMA quality guideline: Structure and core requirements (II)
  • Finished product: contents of module 3.2.P for the different types of radiopharmaceuticals.
    • Drug product (for ready for use radiopharmaceuticals and radionuclide precursors)
    • Drug product (for radionuclide generator)
    • Drug product (for kits for radiopharmaceutical preparation)

12:30 Lunch break


13:30

Dr Natalia Ladygina

CDMO contribution to CMC strategy and regulatory dossier integration in radiopharmaceuticals
  • CMC data integration: ASMF, CEP, and unreferenced Master Files pathways in regulatory dossiers.
  • Comparison of the regulatory pathways, including their suitability across development stages (e.g. clinical vs. MAA).
  • Clarification of sponsor vs. CDMO responsibilities during dossier preparation.
  • Practical integration of CDMO data into CTD Module 3 (e.g. chemical precursors, radiolabelled drug substances, and other materials such as reagents and cassettes).
  • Management of critical quality risks, including extractables and leachables (E&L), transmissible spongiform encephalopathies (TSE)/bovine spongiform encephalopathy (BSE), and nitrosamines data.
  • Future outlook and practical recommendations to build robust and consistent regulatory dossiers (including emerging EU additional quality master file system).

14:45 Biobreak


15:00

Steffi Wittmann

The sponsors perspective: Owning CMC strategy across the lifecycle
  • Strategic CMC planning across development stages:Phase-appropriate data packages and regulatory expectations
    • From IMP to marketing authorization: Bridging development and commercial requirements
  • CDMO oversight from a regulatory perspective: Ensuring data consistency and submission readiness
  • Variation management and lifecycle planning: Typical CMC changes, regulatory impact and submission strategy
  • Navigating regulatory uncertainty as a sponsor
    • Interpreting guidelines, managing regional differences and aligning cross-functional input
    • Proactive Health Authority interaction and adapting to evolving regulatory expectations
  • Lessons learned: Common pitfalls in CMC strategy, and how to prevent them

16:30 Recap and outstanding questions


17:00 End of seminar


More information

Modular qualification course CMC-Specialist in Regulatory Affairs

This seminar is an elective module within our training program CMC Specialist in Regulatory Affairs.

    • This seminar can be taken as an optional module within our training program.
        • The course structure:
          You attend our foundation course ‘CMC Management in Regulatory Affairs’
          You then take part in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
          • You receive structured professional development and comprehensive knowledge on topics relevant to CMC Management
          You can specialise by selecting seminars tailored to your specific area of work
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On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

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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.

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