Professional Development Courses

Achieving Continuing Professional Development (CPD) and Continuing Education Unit (CEU) is not just about learning it is about becoming a better professional. Authorities and Professional Associations require that all persons engage with Continuous Education and Continuous Professional Development programs to assure their fitness to practice.

Professional training is provided over a 6-12month period consisting of a combination of 2-4 day workshops held at regional centres, online eLearning courses, and tutorial webinars for assessing assignments. A certificate or diploma will be awarded as qualification on successfully completing a course and a record of all CPD training undertaken for use when re licencing to practice with a Professional Association or regulatory authority.

All courses provide an interactive practical overview, and consist of Presentations, case studies, group exercises and discussions, and the course papers include;

  • Detailed notes and copies of all presentations.
  • Work book in which the candidate will be provided with information necessary to complete the exercises included in the courses and a reading list should the attendee wish to continue with further studies.
  • A short assessment of the attendees understanding of the course.
  • A CPE/CPD Accredited Professional certificate is awarded on completion which is added to your personalized electronic Training record of CPE/CPD courses completed for submission to Regulatory Authority and/or Professional associations for the recognition of eligibility of persons carrying out positions requiring registration.

PharmaConsult Global provides the following Professional Development courses;

1. Pharmaceutical Product Development

The major focus of the program is to develop the knowledge and understanding necessary for teams to devise a good regulatory strategy for continuous project assessment resulting in prompt regulatory and PharmacoEconomic acceptance of the developed product and representatives must be knowledgeable about all disciplines impacting the development of a product, as well as the regulatory challenges themselves.

During the session the trainers will address the interaction of drug development disciplines, such as molecular characterization, stability, and specification development, both with each other and with the regulatory affairs function, in order to help improve cooperation within R&D and the regulatory team. Developments; focus on best contemporary management practice; and aim to provide both theoretical and hands-on understanding of issues affecting the business environment. A series on work-related assignments via the secure on-line eLearning and webinars (link provided at www.pharmaconsultglobal.com) are assigned to each Delegate to allow deeper, critical assessments and study.

The Professional Development Programme in Product Development consists of;

  • Foundation course consisting of a four day workshop on “Master Class in Pharmaceutical Product Development (PD-1)” This Professional development training course is for Pharmaceutical Scientists engaged in all aspects of research and development.
  • A series of blended learning programs consisting of an on-site workshop, Tutorial webinars for one-on-one directed self-study,
  • Further eLearning courses are available Online as part of this Professional Development Couse, for details please visit; www.pharmaconsultglobal.com/Training.html

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2. Professional Certification in Good Clinical Practice for members of Clinical Investigation Teams (GCP1)

This Professional Development program provides the Profession Certification for Clinical Investigation teams are usually required by Sponsors organisations to prove their fitness to conduct a Clinical Trial before the start of a clinical investigation.

The program consists of;

  • A Foundation course consisting of a one day workshop or eLearning course on; “(GCP-1) Professional Certification in GCP for clinical Investigation Teams” This 2 day Worksop is a key requirement for those involved with the conduct of clinical research is Good Clinical Practice (GCP) training. GCP is the standard and guidelines to which all research is conducted and will include detail on regulatory compliance with the international standards for GCP , GMP and GLP necessary in the conduct of all clinical trials.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors

 

  • Tutorial webinars webinars based on the ICH guidelines E6 Good Clinical Practice (GCP), which includes detail on regulatory compliance with the international standards for Good Clinical Practice GCP, Good Manufacturing Practice (GMP) for manufacture of investigational drug and Good Laboratory Practice (GLP) necessary when running all clinical trials.
  • Further eLearning lectures are available for renewal of the Certificate of Competency to practice, for details please visit; http://www.pharmaconsultglobal.com/Training.html

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3. Professional Certification for Qualified Persons (Quality) (QMS- 5)

This Professional Development Program is for Quality management Professionals and those wishing to register as an EU GMP Guideline implementing EU Directives 2003/94 and GMP Guide Annex’s Qualified Person (QP) and for those professionals wishing to maintain their Continuing Education and Professional development by referring to refresher courses. The program consists of;

  • A Foundation course consisting of a 3 Day Workshop on; “Certification Master Class for Qualified Person (Quality) (QMS-5)" This course is based on ICH guidelines Q10, EU Directive 2001/83, 2003/94 and GMP Guideline Vol 4 and its relevant Annex’s, but the course material will be modified according to local regional requirements.
  • Tutorial webinars and eLearning lectures will be provided as part of this certificated course to address day to day issues which the QP (Quality) might be required to address.
  • As part of your Continuing education program we will provide a comprehensive library of eLectures on topical issues for the Quality Professional. for details please visit; http://www.pharmaconsultglobal.com/Training.html

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4. Professional Certification for Responsible Person (Pharmacist) Distribution.

This Professional Development Program comprises of

  • This eLearning foundation course on; Certification for Responsible Person (Pharmacist) Distribution (GDP_1) Is for those wishing to be named as the Responsible Pharmacist for the Distribution of Medicinal products and is based on the international regulations for Good Distribution Practice (GDP) of pharmaceutical products for human use. The training reviews the practices of wholesale distributors and the proper ways and processes for the distribution of medicinal products, as well as the roles and responsibilities of all personnel stated in the GDP regulations. It discusses the new EU Guidelines 2013/C 343/01 and measures the impact of the new Falsified Medicines Directive and increasing standards required in a compliant supply chain. The course also takes a detailed look into what are the most important aspects of GDP and provides all trainees with all the most relevant information needed for applying Good Distribution Practices in their work.
  • A Tutorial webinar will be provided as part of this certificated course to address any regional variations and day to day issues which the RP (Distribution) might be required to address.
  • Further eLearning lectures are available for renewal of the Certificate of Competency to practice, for details please visit; http://www.pharmaconsultglobal.com/Training.html

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5. Professional Certification for the QP PV (PV-2).

This 2 day course will provide you with a complete guide to the Pharmacovigilance knowledge necessary to carry out the duties of the Qualified Person to monitor drug safety and to comply with the Drug safety standards when reviewing product on sale and assess your skills and competencies for nomination as a QPPV by the appropriate regulatory authority.

This professional Development Program;

  • The foundation course 2 day will provide you with a complete guide to the Pharmacovigilance knowledge necessary to carry out the duties of the Qualified Person to monitor drug safety and to comply with the Drug safety standards when reviewing product on sale and assess your skills and competencies for nomination as a QPPV by the appropriate regulatory authority. Drug Regulatory Authorities require that all Healthcare Professionals observe the systems for Pharmacovigilance and regularly report on the adverse effect profile of all drugs.
  • Tutorial webinars and eLearning lectures will be provided as part of this certificated course to address day to day issues which the QP PV might be required to address.
  • As part of your Continuing education program we will provide a comprehensive library of eLectures on topical issues for the QPPV. For details please visit; http://www.pharmaconsultglobal.com/Training.html

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