How do you get a CEP certificate?

ECA certification is a prerequisite to becoming a CEP. To earn the CEP designation, individuals must pass all three exams, thus demonstrating mastery of equity compensation related issues in all of the core disciplines.

How do you search the CEP in EDQM?

A public list of CEPs is available on the EDQM Certification Database. You can search this database to find CEPs using the CEP number if you know it, or using other criteria such as substance name, etc. Instructions on how to search are provided on the search pages of the database.

What is EDQM certificate of suitability?

The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP).

What is CEP certificate?

An API’s (active pharmaceutical ingredient) Certificate of Suitability (CEP) proves that its quality complies with the quality described in the relevant monograph of the European Pharmacopoeia; it therefore creates a direct link to the Ph. Eur.

How long is the CEP exam?

5 hour
While the 5 hour test can seem daunting and sifting through the endless questions about taxation, accounting and regulations can feel intimidating, there are a few tricks that will put you on the track to acing the exam.

What is CEP and DMF?

The applicant of the product registration shall submit the DMF or the Certificate of Suitability (CEP) with the product registration dossier. • The DMF holder may submit the DMF via electronic copy (CD) and hardcopy (optional) directly to NPCB to maintain confidentiality of the contents.

What is the difference between Asmf and CEP?

Unlike ASMFs, CEP is a stand-alone document reviewed by EDQM, whereas ASMFs can go through several assessments by different Member States. Additional question related to API are rarely raised when CEP is used. When using a CEP, it is possible that you will have less variations during your product’s lifecycle.

Are CEP exams hard?

The CEPI exam curriculum is challenging and in-depth, covering accounting, corporate and securities laws, taxation, plan design, analysis, and administration, ensuring that CEP designees achieve the required high level of expertise in all of the relevant areas of equity compensation.

What is ECA designation?

Equity Compensation Associate (ECA) is the CEP Institute’s new designation for individuals in equity compensation. An ECA is qualified in the fundamentals of equity compensation taxation, plan design, law, and very basic accounting, and can address these topics intelligently with equity plan participants.

What is the difference between dossier and DMF?

As I know, Drug master file has information of the manufactured product while dossier is an application submitted to the regulatory agencies. Drug Master file is part of 3.2. S of the dossier which contains information regarding API only where as the dossier is submitted for the finished pharmaceutical product.

What are the types of DMF?

Types of Drug Master Files (DMFs)

  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product.
  • Type III Packaging Material.
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
  • Type V FDA-Accepted Reference Information.