Certificate of Pharmaceutical Product (CPP) – Global Role, Specifics & Practical Handling
In today’s increasingly globalised pharmaceutical landscape, companies are facing growing demands for rapid market access, regulatory alignment, and assurance of product quality across diverse regions. As expansion into new territories outside EU or US accelerates, regulatory professionals must navigate a complex matrix of national requirements and administrative expectations.
Among these, one document stands out as a vital regulatory instrument for global submissions: the Certificate of Pharmaceutical Product (CPP).
This focused training provides regulatory affairs professionals with in-depth knowledge and practical understanding of the CPP—an essential administrative tool under the WHO Certification Scheme. It plays a critical role in facilitating access to international markets, supporting fast-track reviews, and confirming product quality, safety, efficacy, GMP compliance, and marketing status in the reference country.
Why Attend?
Whether you are supporting new marketing authorisation applications, site transfers, renewals, or product tenders in MENA, Asia, Africa, or Latin America, a solid grasp of CPP processes is indispensable.
CPPs are also critical in scenarios involving mergers and acquisitions (M&As) or in-licensing arrangements, especially when portfolios include territories world-wide where the product lifecycle heavily relies on CPP-based approvals. Despite the harmonised WHO scheme, many key procedural and coordination steps remain country-specific and are often learned through hands-on experience only.
This training offers a unique opportunity to gain those insights—enabling professionals to be well prepared, avoid delays, reduce regulatory costs, and ensure that accurate and compliant information is submitted to meet the expectations of requesting National Competent Authorities.
What You Will Learn:
- The regulatory framework and global significance of CPPs under the WHO Scheme
- Procedural specifics and best practices for obtaining CPPs from major agencies (e.g., Swissmedic, EMA, FDA, BfArM)
- CPP content and structure, including QSE verification, manufacturing site information, and marketing status
- Legalisation and eCPP considerations, including verification methods and current challenges
- Practical case studies illustrating unexpected scenarios and regulatory solutions
Designed by regulatory experts and based on real case scenarios, this training is an essential resource for RA professionals navigating international submissions and lifecycle management.
Live: November 6th | 10:00 – 11:00 CET
Duration: approx. 60 minutes
Presentation language: English
Recording from 11/2025
Speaker: Maryna Pokrovska
Especially for groups - Your benefits at a glance
- Attractive special prices or discounts for entire teams or small groups.
- On request, we offer customised inhouse-packages that are perfectly tailored to the needs of your department or company.
- Book Streaming+ option: Take advantage of our flexible Streaming+ format, which also allows you to have an interactive live Q&A session with the speaker to clarify your questions directly with the expert.
Feel free to contact us by email at info(at)alphatopics.de or by phone - we look forward to your enquiry.
Note on contingent call-off: When booking this webinar described here, one unit will be deducted per participant.
- Maryna Pokrovska
THE FORCE CT GmbH
E-Learning | Streaming in MP4 format (EN)
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
Consent to photographs and film recordings as well as their publication: We would like to point out that photographs and film recordings are taken during our events by persons or service providers commissioned and authorised by us for the documentation of our events (legal basis Art. 6 para. 1 lit. f DSGVO). The recordings serve our public relations work as well as the use, publication and distribution in print, digital and online media, such as newsletters, websites, brochures, flyers and social networks. In this context, it is pointed out in particular that photos and videos on the internet can be accessed by any person. It cannot be ruled out that such persons will continue to use the photos/videos or pass them on to other persons. By registering for and participating in the event, you agree that the organiser is permitted to publish photos, audio and/or film contributions taken at the event without restriction, including for advertising purposes, across all media without permission or remuneration. You have the right to revoke this consent at any time. The revocation of consent does not affect the lawfulness of the processing carried out on the basis of the consent until the revocation. This means that consent can be revoked with effect for the future. We will then immediately remove your photo/video from our website. In this case, please send your revocation to info(at)alphatopivs.de, stating the event.
Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
You are interested in a live event but don't have time on the scheduled day of the live webinar?
Then simply ignore the reminder emails about the live event. Our webinar platform will register that you were not present. As soon as the webinar has taken place, you will automatically receive an email from us a few hours later with your personal link to stream the webinar. You can then watch the webinar - individually - whenever your schedule allows. If you have any questions about the content, you are welcome to send them later to fragen@alphatopics(dot)de.
Note on contingent retrieval:
When booking via your company contingent, please note the separate note in the description of the webinar as to how many parts will be deducted from your contingent for the selected webinar, or webinar series.
Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.