Access the European Market: The Steps for a Flawless Product Launch


CET Berlin
16:00 - 17:30


Apr 25 2023

Learning Type

Free Live Webinar


It is not uncommon for organizations to follow a global expansion strategy when commercializing their drug products, i.e., start in their domestic market, then expand to nearby regions before finally launching in international markets. For non-EU companies to expand into Europe, they must apply for the appropriate product, import, and distribution authorizations to get their drug fully commercialized and into these new markets.

There can often be knowledge gaps within the company, and they would need to become more familiar with the EU regulatory landscape and the organizational and QMS requirements to launch in Europe. This webinar will provide an overview of the EU regulatory environment and outline how your organization can navigate this complex system successfully. It will also highlight some key practical steps you can take now to be ready when it comes time to market your product in Europe.

One of the most important things to remember when planning for EU distribution is that it is a complex process and will take time. It cannot be rushed or done without proper planning and preparation. The first step is determining the authorizations needed for your product(s). You may find yourself in this position and have a blockbuster drug or competitive generic, and you feel the time is right to bring it to market in the EU.

There are different authorizations required, and the QMS and organizational structures need to be put in place for each one and an inspection completed by the competent authority in the country of operation.

The authorization types are:

  • Manufacturers and Importers Authorisation (MIA) – for the site importing the drug.
  • Wholesale Distribution Authorisation (WDA) – For the site and depots distributing the drug in the EU.

Each of these authorizations requires a Pharmaceutical Quality Management system with the personnel, training, and procedures to support each and partner organizations such as third-party logistics providers to warehouse and transport the products. The EU requires that all manufacturers of human medicines have an approved PQMS before they can market their products in the EU.

A competent authority must approve the PQMS as part of an inspection to confirm compliance with EU GMP. While the requirement to have a QMS is universal across all types of pharmaceutical operations, the detail of what that procedure should contain will rarely be identical.

It is important to consider the following when developing your QMS to EU standards:

  • What regulatory standard do you need your QMS to deliver operational compliance?
  • What Quality Culture do you want our organization to have (top-down or bottom-up)?
  • Do you want quality compliance to be policed or embedded in everything you do?
  • What resources will you have to manage, implement and embed the QMS into everyday operations?

Once, as a senior management team, you have asked these questions and used them to prepare a quality policy, you can start putting together the various policies and SOPs.

In this 1.5-hour webinar, we will introduce some of the common supply models and the associated Authorisations, partner requirements, organizational structure, and QMS requirements for each one and talk about what it takes to make a scalable, compliant, and sustainable QMS.

Register now and join us on the 25. April 2023 to ensure you are equipped and prepared to manage the quality and regulatory requirements to launch your existing pharmaceutical products in Europe!

  • Who Should Attend:
    • Head of Quality
    • Head of Regulatory Compliance
    • Compliance Managers
    • QA Managers
    • Regulatory Managers
    • Technical Directors
    • Technical Transfer / NPI Specialists
  • Skill Level: Novice, Intermediate , Expert
  • Topics:
    • Introductions
    • Basic Licencing requirements
    • Some supply models and associated partner / Org requirements
    • QMS Elements – what is needed for each license
    • Modifying global procedures to incorporate EU regulations
    • Summary and questions
  • Special event information:
    • Live attendees will receive a complimentary certificate of attendance.


  • Charley Maxwell
    Charley Maxwell
    Managing Director & Consultant QP / RP

    Charley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor’s of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.

Orion GXP Consulting


Orion GXP Consulting

Orion GxP Consulting provides contract QP and RP services and consultancy support to pharmaceutical manufacturing and distribution clients, such as training and expert knowledge. Orion GMP Consulting draws on the experience of our consultants and their links to the pharmaceutical industry through consulting and QP/RP roles to assist their clients in developing, managing, and continuously improving their quality systems.

What people are saying

Are You Ready To join us?

Event Registration

Local Time

  • Timezone: America/Los_Angeles
  • Date: Apr 25 2023
  • Time: 07:00 - 08:30

*Please double-check the correctness of the information, such as email and full name. It is used for providing personal access link and issuing the certificate of attendance. Changes to names on the certificate won’t be possible after issuing.

Share This Event:


Please check your spam folder. If the email landed in spam, make sure to add us as a contact, so it doesn’t happen again. 

If the email is not in the spam folder, please try using a different email address. Sometimes, company security measures intercept email before they get to your mailbox. 

If you get an error when clicking the confirmation link, it has probably something to do with a company internal security measures that change the link.

Please try registering again and opening the email on another device or forwarding the email to your private email.

If everything fails, please register with your private email address. 

If you attend the live session you will get a digital certificate of attendance emailed to you within 7-working days. 

Yes, our event partners will email you the event recording within several weeks. 

Leave a Reply

Your email address will not be published. Required fields are marked *


Weekly Industry Insights &
tips for success

Join thousands of pharma professionals on an enlightening journey. 

Subscribe to our weekly newsletter to stay current with the latest industry trends, compliance and skyrocket your career.