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.