Radiopharmaceuticals: A practical CMC and quality perspective
Navigating current and future EMA requirements/EU regulatory standards
- 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
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
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.
Your speakers
Fernando Blanco Rodríguez
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, SPAIN
Chemical and Pharmaceutical Division
Fernando Blanco is a healthcare and regulatory professional with a degree in Chemistry…
Your speaker
Fernando Blanco Rodríguez
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Madrid, SPAIN
Chemical and Pharmaceutical Division
Fernando Blanco is a healthcare and regulatory professional with a degree in Chemistry (specializing in Organic Chemistry) and expertise in Clinical Analysis and Radiopharmacy.
With over two decades of experience in quality assurance, he currently serves as a Quality Assessor at the Spanish Agency of Medicines and Medical Devices (AEMPS) and contributes to the European Pharmacopoeia as an expert in radiopharmaceutical preparations.
Dr Natalia Ladygina
Trasis SA,
Ans, BELGIUM
Regulatory Affairs CMC Expert Radiopharmaceuticals
Natalia holds a background in biology with 10 years of research experience. She subsequently transitioned into regulatory…
Your speaker
Dr Natalia Ladygina
Trasis SA,
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.
Steffi Wittmann
ITM Isotope Technologies Munich SE, Garching, GERMANY
Senior Regulatory Affairs CMC Manager
Steffi Wittmann is a pharmacist with over ten years of experience in the pharmaceutical industry, currently…
Your speaker
Steffi Wittmann
ITM Isotope Technologies Munich SE, 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.
What to Expect
- 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.
Objective of the Event
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.
Programme
from 9:00 am until 5:00 pm CET
09:00
09:15
Fernando Blanco Rodríguez
- 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: Content 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
11:00
Fernando Blanco Rodríguez
- Finished product: Content 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
13:30
Dr Natalia Ladygina
- CMC data integration: ASMF, CEP, and unreferenced master file 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 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
15:00
Steffi Wittmann
- Strategic CMC planning across development stages:§§§Phase-appropriate data packages and regulatory expectations
- From IMP to marketing authorisation: 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
17:00
Welcome, introduction, expectations
09:15
The new EMA quality guideline: Structure and core requirements (I)
The new EMA quality guideline: Structure and core requirements (I)
Fernando Blanco Rodríguez
- 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: Content 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)
Biobreak
11:00
The new EMA quality guideline: Structure and core requirements (II)
The new EMA quality guideline: Structure and core requirements (II)
Fernando Blanco Rodríguez
- Finished product: Content 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)
Lunch break
13:30
CDMO contribution to CMC strategy and regulatory dossier integration in radiopharmaceuticals
CDMO contribution to CMC strategy and regulatory dossier integration in radiopharmaceuticals
Dr Natalia Ladygina
- CMC data integration: ASMF, CEP, and unreferenced master file 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 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)
Biobreak
15:00
The sponsors perspective: Owning CMC strategy across the lifecycle
The sponsors perspective: Owning CMC strategy across the lifecycle
Steffi Wittmann
- Strategic CMC planning across development stages:§§§Phase-appropriate data packages and regulatory expectations
- From IMP to marketing authorisation: 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
Recap and outstanding questions
End of seminar
Downloads
brochure
All details and content at a glance.
Abbreviation list_Drug Regulatory Affairs and CMC
Abbreviation list_Drug Regulatory Affairs and CMC
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Modular qualification course CMC-Specialist in Regulatory Affairs
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This seminar can be taken as an optional module within our training program.
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