Master EMA Regulatory Affairs Europe

Master EMA Regulatory Affairs Europe free download

Manage medical devices regulatory activities in the European market /Be the expert of EU market

Master medical devices registration in the most important and biggest market ever in the world, the European market, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.

The regulatory agency in charge of assessing, approving, and overseeing medications inside the European Union (EU) is the European Medicines Agency (EMA). It guarantees the high quality, safety, and efficacy of medications sold in the EU. The

EMA's primary duties include medicine evaluation and approval. centralized process for approving marketing in every EU nation. Scientific committees evaluate new medications. expedited permission (e.g., conditional approvals, fast assessments) for urgent medical requirements. The EudraVigilance system is used for the collection and assessment of adverse drug reactions (ADRs). RMPs (risk management plans) for recently authorized medications. Guidelines & Scientific Research. uses the EU Clinical Trials Information System (CTIS) and the Clinical Trials Regulation (CTR) to oversee clinical trials. Examining and Complying ensures adherence to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) by collaborating with national authorities.

What will you learn?

• Get introduced to EMA

• Master EMA portal

• Master Medical Devices Registration in Europe

• Master Medical Devices Classification in Europe

• Master regulatory harmonization across Europe

• Keep an eye on the updates and each country's response

• MHRA, TGA, and FDA situation and response from EMA

• Master products Importation, renewal, and variation

• EUDAMED database

• EUDRAVIGILANCE

• Shifting to MDR

  
  

  In this course, we will cover all topics related to medical devices in Europe, starting from the requirements, interim regulations, classification, verification, and special conditions. we will get introduced to EMA committees:

  • Committee for Medicinal Products for Human Use (CHMP) – Reviews and approves new medicines.

  • Pharmacovigilance Risk Assessment Committee (PRAC) – Monitors drug safety.

  • Committee for Orphan Medicinal Products (COMP) – Manages rare disease treatments.

  • Committee for Advanced Therapies (CAT) – Assesses gene and cell therapies.

  Will Explore together EMA regulatory pathways and how to choose the best one suitable for which product

• Centralized Procedure (mandatory for biotech, orphan, and advanced therapies)

• Decentralized Procedure (for medicines not covered by the centralized route)

• Mutual Recognition Procedure (MRP) (approval in one EU country extended to others)

• National Procedure (only applicable in a single EU member state)

Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, of the medical, and interact with the actual MHRA gateway for the submission. 

and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for the European market importation.

And finally, congratulations to you for mastering medical device registration in the European market and see you soon in the pharma industry my dear colleagues.