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Pharmaceutical Quality and Regulatory Affairs

  • 35 hours
  • 5 days

Overview  

This five-day course provides an overview of manufacture, regulations and quality standards for the pharmaceutical and advanced therapy medical products (ATMP) industry.

You'll learn about current best good manufacturing practice (GMP) in the UK/Europe and the rest of the world, dossier submission and assessment and revisions to (GMP) guidelines.

It will help you facilitate swift and safe access to markets, through successful submissions and examination processes.

This course has been organised by UCL and supported by leading UK pharmaceutical consultants including Q3P and ATMP manufacturers, NHS trusts and Phase 1 clinical trial units. 

Who this course is for  

This course is aimed at:

  • individuals working for the traditional pharmaceutical, advance therapy medicial products (ATMP) and medical devices industry
  • individuals working for regulatory agencies
  • good manufacturing practice (GMP) inspectors
  • pharmaceutical assessors
  • pharmaceutical quality assurance and regulatory affairs professionals involved in medicine manufacture

Course content  

Lecture and practical topics will include:

  • Quality assurance and regulatory affairs involved in pharmaceutical products
  • Challenges in manufacturing of traditional medicines
  • Manufacture, testing and regulations related to ATMP
  • Data integrity
  • GMP inspections
  • Pharmaceutical audits
  • Self-inspection: preparation for GMP inspections
  • Pharmaceutical Inspection Cooperation Scheme (PICS) guidelines
  • Environmental monitoring: Sterile manufacture
  • Analytical methods: Impurity detection
  • Statistics: Quality by design and Product Quality Reviews (PQR)
  • Pharmaceutical Quality Systems: Root Cause Analysis (RCA) and corrective and preventive action (CAPA) management

Teaching and structure  

The course will take place at UCL in London and will also be available synchronously on Zoom. Visits will be filmed and be available live on Zoom. 

Over the five days you'll:

  • participate in interactive talks
  • take part in facilitated workshops within small groups
  • discuss issues with experts in the field
  • network with your regulatory and industry peers
  • visit a pharmaceutical manufacture and packaging facility
  • visit a clinical phase 1 unit
  • visit a NHS ATMP manufacture facility
  • visit a NHS radiopharmaceutical manufacture facility
  • visit GMP & GCLP compliant quality control testing laboratory 

Learning outcomes

This course will help you:

  • make a submission to the respective regulatory authorities
  • prepare for GMP regulatory inspections
  • prepare for, conduct and report on effective external audits
  • understand good manufacturing practices and pharmaceutical quality systems in the pharma industry, including RCA and corrective and preventive action CAPA
  • confidently macro manage teams of manufacturers, regulatory affairs individuals and quality assurance associates

Certificates 

You'll receive a certificate of attendance from UCL and Q3P on completion of the course.

Cost

The fee is £2,000. This includes lunch and refreshments.

Partners

Q3P Limited: Qualified Person Personalised Programme

Ethypharm Phamra: Liquid (sterile and non-sterile) pharmaceutical manufacturer

Aspar Pharma: tablet and capsule manufacturer

UCL ATMP manufacturing facility

UCL Radiopharmaceutical manufacturing unit

Zeta Labs: quality control testing laboratory

QP Quandary

Zaim Pharma: gene and cell therapy QA consultant

Stridon Healthcare: clinical research organisation

HMR & Richmond Pharmacology: Phase 1 clinical trials London

Ammarox Pharma

Course team

Professor Kevin Taylor

Professor Kevin Taylor

Kevin is Professor of Clinical Pharmaceutics at the UCL School of Pharmacy. He's also Chairman of the British Pharmacopoeia Commission, Chairman of the Chemistry and Pharmacy (CAP), member of MHRA’s Commission on Human Medicines CHM (MHRA's dossier assessing committees).

Dr Khalid Sheikh

Dr Khalid Sheikh

Khalid is an Associate Professor at the UCL School of Pharmacy. He's also Director of the Qualified Person Course (QP3), Senior Pharma industry manufacturer, expert in use of Statistics (QBD), regulatory affairs and Quality Management system (QMS) in the pharma industry.

Dr Attia Hasnain

Dr Attia Hasnain

Attia is Director of the Zain Pharma, a leading quality assurance consultant, Qualified Person (QP) at the ATMP manufacture facility at the Great Ormond Street Hospital (GOSH), London, and QP Assessor and formulation science researcher. Attia has extensive experience in quality audits of API, and ATMP manufacturers. In addition, Attia serves as a Qualified Person Assessor at the Royal Pharmaceutical Society

Dr Radivoj Areziena

Dr Radivoj Areziena

 

Radivoj is a QP(IMP) and director at Stridon Healthcare, a leading clinical research organization. Radi was founder of Richmond Pharmacology, a phase 1 clinical trials unit and was involved in conducting of more than 200 clinical trials over two decades. Radi has vast experience of regulatory submissions of clinical trials.

 

James Drinkwater

James Drinkwater

James is Chairman of Pharmaceutical and Healthcare Sciences Society (PHSS) and Chairman of Annex 1 revision committee of the PHSS and Pharmaceutical Quality Group (PQG). 

James has extensive experience in sterile manufacture of pharmaceutical products. He heads the Quality department of a German– based Isolator manufacturer.

Dr Gazala Ahmed

Dr Gazala Ahmed

Gazala is a senior regulatory affairs individual. She is head of the Regulatory Affairs department at Waymed Pharma UK and responsible for marketing authorization dossiers, and variations submissions.

Arvind Vijayabhaskar

Arvind Vijayabhaskar

Arvind is a senior Qualified Person who has worked at leading pharmaceutical industries including Novartis. Arvind is an accredited auditor and helped secure marketing authorizations for various UK-based pharmaceutical companies. He has extensive experience in dossier submission to the UK and EU regulators.

Annika Boloz

Annika Boloz

Annika is a registered pharmacist and Director of Radiopharmaceuticals at Bristol NHS foundation trust. She has 10 years of experience dealing with the manufacture, quality and regulations of radiopharamceuticals.

Dr Timothy Sandle

Dr Timothy Sandle

Tim is a senior Quality Assurance individual involved in environmental monitoring in sterile manufacture of blood products. Tim is author of a number of books on QA in Sterile manufacture. Tim has vast experience of legislation involving sterile manufacture in the UK, EU and the USA. Tim is working as the Head of Quality at Blood Products Limited (BPL) and teaches the Sterile manufacture module on UCL’s Qualified Person course.

Alex Hall

Alex Hall

Alex is a senior Quality Assurance professional with more than 30 years of experience in the pharma industry and clinical trials. Alex is a senior Qualified Person and was the Chief Assessor at the RSC for 10 years. Alex is a tutor at the UCL’s QP Course and teaches Quality Assurance, regulatory aspects of clinical trials and manufacture of small molecules.

Carol O'Sullivan

Carol O'Sullivan

 

Carol is a Qualified Person for Pharmacovigilance and Medical Devices at the PBC Biomed, Ireland. Carol is well versed in manufacture, packaging and labelling, quality and risk assessment of Medical Devices.

 

Mayur Gohil

Mayur Gohil

Mayur is a Qualified Person at the Zeta Labs, and Managing Director. He has over 30 years of experience in QC testing of API and finished pharmaceutical products. Mayur and his team are key collaborator of UCL’s QP course.

Course information last modified: 7 Dec 2022, 17:03