Webcast: Update EU Pharma Legislation
Clear guidance on upcoming EU requirements in a five-module webcast series
- Recorded online-webcasts over five sessions
- Concise update & maximum flexibility
- Prepare for the new Pharma Legislation
- Officially certified according to ISO 9001 and 21001

Series (completed)
Ab
1.590,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.590,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
each from 9:00 a.m. - 11:00 a.m. CET:
06.04.2027
07.04.2027
16.04.2027
21.04.2027
27.04.2027
Buchungsdetails
Series (completed)
Ab
1.590,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.590,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
each from 9:00 a.m. - 11:00 a.m. CET:
06.04.2027
07.04.2027
16.04.2027
21.04.2027
27.04.2027
This online webcast series provides a concise update on the EU Pharmaceutical Package. Across five two-hour modules, you learn about key regulatory changes, revised authorisation and protection rules, new obligations for managing shortages, and developments in environmental risk assessment. Gain practical guidance to adapt internal processes and responsibilities to the upcoming framework.
Your speakers
What to Expect
- Module 1: The legal framework part 1 - overview and current procedural status
- Module 2: The legal framework part 2 - protection periods
- Module 3: Regulatory developments & innovations
- Module 4: Supply shortages and supply security
- Module 5: Environmental Risk Assessment (ERA)
Who Should Attend
This webcast is designed for regulatory affairs professionals with a solid background in EU marketing authorisation procedures.
Legal/compliance, quality, pharmacovigilance and related professionals involved in planning and implementing EU regulatory requirements will also benefit from this course.
Objective of the Event
This webcast series provides a structured, practice-oriented update on the EU pharmaceutical reform. Across five recorded online sessions, participants gain clarity on the proposals' scope, timelines and operational impact.
The training translates legislative changes into day-to-day regulatory, quality and compliance tasks, including dossier planning and internal coordination. It highlights interfaces with existing EU instruments and emerging guidance to support informed, timely implementation. By the end, attendees will be able to assess the relevance of key reforms for their portfolios and set up proportionate measures to ensure ongoing compliance across the product life cycle.
All five modules will be recorded and made available to the participants afterwards. This offers maximum flexibility and allows to revisit the content whenever needed.
Your Benefit
- Focused two-hour online modules with dedicated Q&A sessions held during the live modules
- Recording of all modules - for maximum flexibility and self-paced revision
- Orientation on data/market protection and incentives affecting launch planning
- Guidance on updating internal procedures and documentation
- Insights on shortages prevention & new ERA rules
Programme
from 9:00 a.m. to 11:00 a.m. CET
09:00 - 11:00
Dr. Alexander Meier
- Current status of the legislative process at EU level
- Overview of the new Regulation (procedure 2023/0131/COD) and the new Directive (procedure 2023/0132/COD)
- Impact on other legal acts (Variation Regulation, Critical Medicines Act, etc.)
- ePI - current legal status & regulatory requirements
09:00 - 11:00
Dr. Alexander Meier
- Changes to regulatory protection periods for medicinal products and orphan drugs (new Bolar exemption rule, launch conditionality, etc.)
- New incentives for antibiotic development (such as transferable exclusivity voucher)
- Repurposing - new rules for the reuse of known active substances
09:00 - 11:00
Britta Ginnow
- Updates related to marketing authorisation procedures (e.g. Rolling Review, Prime, well-established use)
- Regulatory sandboxes and platform technologies and their relevance for new MAAs
- Regulatory simplifications (e.g. renewal, sunset clause, Risk Management Plan)
- Role of new data sources in authorisation (RWD/RWE, big data, etc.)
09:00 - 11:00
Anna Wehage
- New obligations for shortage prevention and risk planning
- Coordination between the EMA, national competent authorities (NCAs), and pharmaceutical companies
- Reporting and monitoring obligations, EU mechanisms for shortage analysis
- Practical implications for manufacturers, marketing authorisation holders, and supply chain management
- Interplay with the Critical Medicines Act
09:00 - 11:00
Dr. Angela Vogt-Eisele
- Current legal framework and regulatory requirements
- Why the current requirements are tightened
- Changes and unknowns in the proposed directive
- Integration of ERAs into lifecycle management
- Handling of legacy compounds (authorised before 2006)
- Special cases: Endocrine and persistent active substances
- The role of antimicrobial resistance (AMR)
- Transparency and public access to ERA data
09:00 - 11:00
Module 1: The legal framework part 1 - overview and current procedural status
Module 1: The legal framework part 1 - overview and current procedural status
Dr. Alexander Meier
- Current status of the legislative process at EU level
- Overview of the new Regulation (procedure 2023/0131/COD) and the new Directive (procedure 2023/0132/COD)
- Impact on other legal acts (Variation Regulation, Critical Medicines Act, etc.)
- ePI - current legal status & regulatory requirements
09:00 - 11:00
Module 2: The legal framework part 2 - protection periods
Module 2: The legal framework part 2 - protection periods
Dr. Alexander Meier
- Changes to regulatory protection periods for medicinal products and orphan drugs (new Bolar exemption rule, launch conditionality, etc.)
- New incentives for antibiotic development (such as transferable exclusivity voucher)
- Repurposing - new rules for the reuse of known active substances
09:00 - 11:00
Module 3: Regulatory developments & innovations
Module 3: Regulatory developments & innovations
Britta Ginnow
- Updates related to marketing authorisation procedures (e.g. Rolling Review, Prime, well-established use)
- Regulatory sandboxes and platform technologies and their relevance for new MAAs
- Regulatory simplifications (e.g. renewal, sunset clause, Risk Management Plan)
- Role of new data sources in authorisation (RWD/RWE, big data, etc.)
09:00 - 11:00
Module 4: Supply shortages and supply security
Module 4: Supply shortages and supply security
Anna Wehage
- New obligations for shortage prevention and risk planning
- Coordination between the EMA, national competent authorities (NCAs), and pharmaceutical companies
- Reporting and monitoring obligations, EU mechanisms for shortage analysis
- Practical implications for manufacturers, marketing authorisation holders, and supply chain management
- Interplay with the Critical Medicines Act
09:00 - 11:00
Module 5: Environmental Risk Assessment (ERA)
Module 5: Environmental Risk Assessment (ERA)
Dr. Angela Vogt-Eisele
- Current legal framework and regulatory requirements
- Why the current requirements are tightened
- Changes and unknowns in the proposed directive
- Integration of ERAs into lifecycle management
- Handling of legacy compounds (authorised before 2006)
- Special cases: Endocrine and persistent active substances
- The role of antimicrobial resistance (AMR)
- Transparency and public access to ERA data
More Options
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Downloads
Request the documents using our form.

Brochure

List of abbreviations "Drug Regulatory Affairs and CMC"
Further Informations
Modular webcast - maximum flexibility
All five modules will be recorded and made available to the participants afterwards.
This gives you the opportunity to revisit the content flexibly and at your own pace or to review specific topics whenever needed. In this way, the training can be integrated smoothly into your working routine. The recordings will be available for up to 90 days after the live sessions.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
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.
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
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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Further Information
Your Contact Person
We are happy to advise you personally and individually.

Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de






