WorkshopTraining Services

 Pharma Consult’s approach to providing Training is by outlining the necessary skills, competencies and qualifications needed to perform a given role, and to developing these in a language which is appropriate to the individual, so that employers will be able to access advancement in their chosen career pathways encouraging a lifelong approach to learning and career development.

All our Continuing Education courses have been independently accredited by “The CPD Accreditation Service”, to ensure that they are of the highest quality and are consistent with International Standards, and designed to support Continuous Professional Development programs.

We achieve this by ensuring:

  • Presenting lectures and tutorials which are clear and focused.
  • Supporting what we say with illustrations taken from case studies in industry
  • Using clear visual aids which enhance the message
  • Allowing ample time for discussion with delegates – during presentations as well as after
  • Promoting understanding and involvement of all attendees via the use of interactive sessions and use of electronic response cards and using techniques such as teamwork tasks and group workshops.

Many of our training courses are used, to prepare delegates for the examinations for Professional qualifications and are recognized as part of your Continued Professional Development. Our commitment to the client and the delegates does not end when the course finishes. We encourage companies and individuals to contact us if they feel we can assist with explaining issues further, problem solving, guidance on where to find relevant documents, further reading and so on.

On Site Training; Workshops and seminars

We provide Public and Company workshops and Seminars prepared on a range of specialist subjects relevant to the region and topic presented.

On- site training courses can vary in duration from half a day up to five days, and public seminars are usually of 2-4 days in duration, and always in small groups so as to allow for detailed discussion on the topic in question.

We strongly believe that training is most effective when it is directly relevant to the activities performed by the attendees. With that in mind, we like to work closely with you to design courses which your staff can immediately relate to and which answer their specific questions.

Summary of Training Workshops available from PharmaConsult Global

1. Pharmaceutical Developments

1.1 (PD-1) Introductions to Pharmaceutical Development.

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.

While developing drugs there are issues, tasks, regulations & procedures that have to consider

An overview of the current product and process knowledge required when developing large molecule products, and the latest information for the developments in personalized medicine and why it is required. The topics covered will include:

  • Genomics: How genomics data are being sequenced and collated gathered
  • Use of genomics data in drug discovery
  • Biomarkers in disease detection; and
  • Delivery of personalized medicine: targeted therapeutics

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1.2 (PD-2) Introduction to Biopharmaceuticals and Biosimilar

This intensive Two day Workshop will consider the Fundamentals of Biotech Drug Products their Manufacture and key Regulatory Concerns for the review of biotech/bio similar drug products, and will take delegates through a step wise approach to evaluating the manufacture of new sources of supply of Biotechnology products.

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1.3 (PD -3) Fostering a culture of innovation for Growth

The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.

Included in the course content of this two day workshop is an overview of the regulatory and pre-marketing steps that occur to ensure a successful Product launch.

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2. Good Clinical Practice – GCP

2.1 (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 trails

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

 

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2.2 (GCP-2) Strategies for Design and Monitoring Clinical Trials.

This essential 2-day course will provide you with the latest updates on different strategies for design and monitoring clinical trials to reduce costs and ensure regulatory compliance, ensuring that GCP is maintained throughout the trail, and with practical sessions to guide you through each of the key monitoring procedures.

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3. Medical devices

3.1 (Med-1) An Introduction to Registration of Medical devices

This 3 day workshop is designed to enable delegates to learn more about the new initiatives in the format and review of Technical Documentation for Medical Devices. It is relevant to all who have to compile and review such documentation to define the essential requirements that medical devices must meet before being placed on the market by comparing European, US and Saudi Regulations.

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4. Pharmaceutical Product Registration

4.1 (Reg-1) Introductions to Regulatory Affairs

This 3 day workshops will provide new graduates recruited in to the pharmaceutical industry as an introduction to Regulatory Compliance in the Pharmaceutical Industry and Good Practice for Manufacturing, Laboratory. Clinical Pharmacovigilance and Distribution.

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4.2 (Reg-2) Introductions to Common Technical Documentation

This 4 day workshops will provide new graduates recruited in to the pharmaceutical industry as an introduction in to Drug Regulatory Processes necessary to prepare data and to publish in Common Technical Documentation and published in a NeeS or eCTD dossier formats.

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5. Pharmaceutical Quality Management-QMS

5.1 (QMS-1) Pharmaceutical Quality Management

This is a 3 Day practical course which focuses on the risk based assessment of Pharmaceutical Product and Process development, the preparation of appropriate data required for inclusion in a new Product Drug dossier and ensuring compliance with the regulations for Good Manufacturing Practice.

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5.2 (QMS-2) Quality by Design in Product Development

This is a 2 day practical intensive course that focuses on the risk based approach to ensuring flexibility in the Pharmaceutical Product and Manufacturing Process (Quality by Design), identifying criteria which are critical to Quality (Process Analytical Technology) and Validating the manufacturing Process.

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5.3(QMS-3) Requirements of an Effective Qualification Programme

This is a practical three day workshop which focuses on the Audit and Inspection Practice for assessing compliance to Good Manufacturing Practice, and by utilizing risk based assessment techniques to minimize potential for process deviations. This course will prepare delegates to carry out a GMP compliance inspection of manufacturing facilities for all common dosage forms and will provide participants with a step–by–step guide to best Inspection Practice and practical experience of conducting an Inspection in a manufacturing facility.

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5.4 (QMS-4) ISO 9001:2015 Implementing NEW Quality management standards

This Three Day workshop will review the changes in ISO 9001:2015 and will address the impact of the changes made to ISO 9001:2008 in meeting the standards for a Quality management systems to establish concepts, principles, guidelines and criteria for maintaining and improving the processes by which an organization defines and achieves its goals.

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5.5 (QMS-5) Certification Master class for Qualified Person (Quality)

This 3 day workshop outlines the Responsibilities of the Qualified Person for Certifying medicinal products for release. The Drug Regulatory Authorities from around the World requires that QP’s releasing Pharmaceutical Products to the market check API and commercial and Investigational products is complies with the registered specification and authenticity of origin of Medicines before release for use.

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6. Good Manufacturing Practice-cGMP

6.1(GMP-1) GMP Requirements for Manufacturing Pharmaceutical Products

This is a practical course focuses on the risk based assessment of Pharmaceutical manufacture, the preparation of appropriate data required for inclusion in a new Product Drug dossier and ensuring compliance with the regulations for Good Manufacturing Practice.

The course will prepare delegates for a GMP Regulatory inspection of facilities to manufacture all common dosage forms and will provide all participants with a step–by–step guide of the regulations, practical sessions and will consider a number of case studies, there will be group discussions on all topics covered in the course.

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6.2 (GMP-2) Master Class in cGMP compliance Auditing and Inspection

This is a practical 2 day workshop which focuses on the GMP regulatory compliance for Manufacturing Pharmaceuticals and outlines the risk based approached of Auditing and Inspection for ensuring compliance with the Registered Product specification and Regulations for Good Manufacturing Practice.

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7. The Principals of Good Distribution Practice- GDP

7.1 Certification for Responsible Person (Pharmacist) Distribution (GDP-1)

The Duties and Responsibilities of the Responsible Person (Pharmacist) ensure the maintenance of the quality and integrity of the Licensees’ medicinal products in accordance with Good Distribution Practice regulations .This workshop and/or eLearning course & webinar will provide instruction in the four competencies specified in the MHRA Gold Standard role profile for the RP, Regulatory compliance, Technical Knowledge, business Improvement Technical requirements.

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8. Good Pharmacovigilance Practice –GVP

8.1 (PV-1) Good Pharmacovigilance Practice

This 2 day course provides a complete guide to clinical and post-marketing pharmacovigilance and the standards for compliance with Guidelines on Good Pharmacovigilance Practice, all Healthcare Professionals observe the systems of monitoring and reporting the adverse effect profile.

This 2 day course provides a complete guide to clinical and post-marketing pharmacovigilance and the standards for compliance with Guidelines on Good Pharmacovigilance Practice, all Healthcare Professionals observe the systems of monitoring and reporting the adverse effect profile.

And course will detail the duties and responsibilities that all Healthcare Professionals observe within the companies Pharmacovigilance Management system for regularly report on the adverse effect profile of all drugs.

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8.2 Certification Master Class for QP PV

This 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.

And course will detail the duties and responsibilities that all Healthcare Professionals observe within the companies Pharmacovigilance Management system for regularly report on the adverse effect profile of all drugs.

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8.3 Drug Safety and Pharmacovigilance (PV-3)

This course delivers comprehensive instruction on drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. It also addresses the pharmacovigilance audit and provides exercises in signaling and data mining. This course explains the regulatory issues across global government agencies that improve safety. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international safety and reporting standards.

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9. Health Economics and Business Development.

9.1 (BA-1) Introduction to Health care Economics

This 2 day workshop will outline the methodologies for undertaking an Economic Assessment of a pharmaceutical product to evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of life) of a pharmaceutical product. And will review the different types of PharmacoEconomic evaluation: cost-minimization analysis, cost-benefit analysis, cost-effectiveness analysis and cost-utility analysis. Value Based Assessment of Heath Technologies- will give more detail about the way “burden of illness” will be assessed and suggest changing “wider societal benefit” into “wider societal impact” which is also defined in the paper.

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9.2(BA-2) Strategic Planning and decision making

This 2 day workshop will examine the factors which are driving change and consider the implications for the individuals and teams tasked with planning and leading that change. Improving performance through learning and leadership; examining frameworks for developing and evaluating healthcare delivery strategies.

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9.3 (BA-3) Project Management

This 2 day Workshop will develop your Project Management skills for planning and managing change in your organization, and ensuring cost effective completion. Some of the examples that will be worked through will be; the preparation of a product dossier in eCTD format, design and build of new facilities, use in progressing clinical trials.

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9.4 (BA-4) Medicines Supply Chain management

The essential elements in Supply chain management (SCM) is the management of business systems and having an effective relationships with supplier, in this two day course we will cover the essential elements to qualify for the Certificate of Procurement and supply operations. It includes the movement and storage of ingredients, work-in-process inventory, and finished goods from point of origin to point of consumption.

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