Training Courses

drug device combination products regulatory quality requirements

Drug-Device Combination Products: Quality & Regulatory Requirements

13. February 2023

bioassay

Development and Validation of Bioassays

27. February 2023

Viral Safety for Biologics online training course for pharmaceutical professionals

Viral Safety for Biologics

27. February 2023

Clinical Outcome Assessments and PROs

Clinical Outcomes Assessments and PROs

6. March 2023

quality requirements for biologics

Quality Requirements for Biologics

6. March 2023

Extractables and Leachables

A Risk-Based Approach to the Control of Extractables and Leachables

6. March 2023

Process Scale-up, Technology Transfer and Process Validation course applying QbD principles.

Process Scale-up, Validation & Technology Transfer

20. March 2023

ANNEX 1

Annex 1 for Medicinal Product Manufacturing

20. March 2023

Orphan Drugs Clinical Trials - Live Online Training

Orphan Drugs Clinical Trials

20. March 2023

CMO Contracting, Oversight and Value Optimisation

CMO Contracting, Oversight and Value Optimisation

22. March 2023

Manufacturing of mRNA-Based Therapeutics

Manufacturing of mRNA-Based Therapeutics

27. March 2023

Pharmaceutical Cleaning Validation online training course

Cleaning Validation in Pharma

27. March 2023

clinical investigation evaluation medical device

Clinical Investigations and Evaluation for Medical Devices

28. March 2023

Advanced Industrial Process and Unit Operations Scale-up

3. April 2023

CMC and Regulatory Requirements for Inhalation Drug Products

8. May 2023

Aseptic Fill & Finish of Biologics & ATMPs online training course

Aseptic Fill & Finish of Biologics & ATMPs

9. May 2023

Online training providing practical insights into injectables

Process Scale-up & Tech Transfer for Injectables

10. May 2023

Project Management for Generics

10. May 2023

Change Management

Change Management for Medical Affairs

22. May 2023

drug device combination products regulatory quality requirements

Drug-Device Combination Products: Quality & Regulatory Requirements (US Edition)

6. June 2023

CMC Regulatory Compliance for Biological Drug Products

12. June 2023

Quality Requirements for Solids

Quality Requirements for Solids

12. June 2023

GMP in API Production

Good Manufacturing Practices in API Production: How to Implement ICHQ7

14. June 2023

process validation scale-up biologics training

Process Scale-up, Validation and Technology Transfer for Biologics

19. June 2023

process and equipment change

Process and Equipment Change Management

19. June 2023

statistics

Statistical Methods Across the Product/ Process Lifecycle

19. June 2023

Bioequivalence and IVIVC, Pharmacokinetics Online live training course

Bioequivalence and IVIVC

paediatric clinical trials training EMA FDA regulatory guidance

Paediatric Drug Development & Clinical Trials

Leverage patient-centric Real-World Evidence (RWE) to accelerate the patient and market access

Real-World Evidence in Rare Diseases: Accelerating Market Access

Aseptic Processing

Aseptic Processing in Manufacture of Sterile Products & ATMPs

Development of Solid Generic Formulations online course

Development of Solid Generic Formulations

Pricing and Market Access of ATMPs online training

Pricing and Market Access of ATMPs

Pharma & Biotech Stability Testing

Pharma & Biotech Stability Testing

Value Added Medicines training for business development professionals

Value Added Medicines / Scientific, Regulatory and IP Analysis

Development of Gene and Cell Therapy Training

Accelerating Development of Gene & Cell Therapy

Medical device training with James Pink

Process Design, Scale-up and Technology Transfer for Medical Devices

This training course integrates the in-vitro dissolution testing, equipment requirements, quality control aspects and using dissolution to obtain biowaivers.

Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers

Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis

GMP and Validation for Equipment Suppliers

Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development

Stability Testing of Biological Drug Products

ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation

Pharmaceutical Data Integrity

Pharmaceutical Data Integrity

drug device combination products regulatory quality requirements

Drug-Device Combination Products: Quality & Regulatory Requirements

13. February 2023

bioassay

Development and Validation of Bioassays

27. February 2023

Viral Safety for Biologics online training course for pharmaceutical professionals

Viral Safety for Biologics

27. February 2023

Clinical Outcome Assessments and PROs

Clinical Outcomes Assessments and PROs

6. March 2023

quality requirements for biologics

Quality Requirements for Biologics

6. March 2023

Extractables and Leachables

A Risk-Based Approach to the Control of Extractables and Leachables

6. March 2023

Process Scale-up, Technology Transfer and Process Validation course applying QbD principles.

Process Scale-up, Validation & Technology Transfer

20. March 2023

ANNEX 1

Annex 1 for Medicinal Product Manufacturing

20. March 2023

Orphan Drugs Clinical Trials - Live Online Training

Orphan Drugs Clinical Trials

20. March 2023

CMO Contracting, Oversight and Value Optimisation

CMO Contracting, Oversight and Value Optimisation

22. March 2023

Manufacturing of mRNA-Based Therapeutics

Manufacturing of mRNA-Based Therapeutics

27. March 2023

Pharmaceutical Cleaning Validation online training course

Cleaning Validation in Pharma

27. March 2023

clinical investigation evaluation medical device

Clinical Investigations and Evaluation for Medical Devices

28. March 2023

CMC and Regulatory Requirements for Inhalation Drug Products

8. May 2023

Aseptic Fill & Finish of Biologics & ATMPs online training course

Aseptic Fill & Finish of Biologics & ATMPs

9. May 2023

Online training providing practical insights into injectables

Process Scale-up & Tech Transfer for Injectables

10. May 2023

Project Management for Generics

10. May 2023

Change Management

Change Management for Medical Affairs

22. May 2023

drug device combination products regulatory quality requirements

Drug-Device Combination Products: Quality & Regulatory Requirements (US Edition)

6. June 2023

CMC Regulatory Compliance for Biological Drug Products

12. June 2023

Quality Requirements for Solids

Quality Requirements for Solids

12. June 2023

GMP in API Production

Good Manufacturing Practices in API Production: How to Implement ICHQ7

14. June 2023

process validation scale-up biologics training

Process Scale-up, Validation and Technology Transfer for Biologics

19. June 2023

process and equipment change

Process and Equipment Change Management

19. June 2023

statistics

Statistical Methods Across the Product/ Process Lifecycle

19. June 2023

Bioequivalence and IVIVC, Pharmacokinetics Online live training course

Bioequivalence and IVIVC

paediatric clinical trials training EMA FDA regulatory guidance

Paediatric Drug Development & Clinical Trials

Leverage patient-centric Real-World Evidence (RWE) to accelerate the patient and market access

Real-World Evidence in Rare Diseases: Accelerating Market Access

Aseptic Processing

Aseptic Processing in Manufacture of Sterile Products & ATMPs

Development of Solid Generic Formulations online course

Development of Solid Generic Formulations

Pricing and Market Access of ATMPs online training

Pricing and Market Access of ATMPs

Pharma & Biotech Stability Testing

Pharma & Biotech Stability Testing

Value Added Medicines training for business development professionals

Value Added Medicines / Scientific, Regulatory and IP Analysis

Development of Gene and Cell Therapy Training

Accelerating Development of Gene & Cell Therapy

This training course integrates the in-vitro dissolution testing, equipment requirements, quality control aspects and using dissolution to obtain biowaivers.

Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers

Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis

GMP and Validation for Equipment Suppliers

Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development

Stability Testing of Biological Drug Products

ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation

Pharmaceutical Data Integrity

Pharmaceutical Data Integrity

drug device combination products regulatory quality requirements

Drug-Device Combination Products: Quality & Regulatory Requirements

13. February 2023

CMC and Regulatory Requirements for Inhalation Drug Products

8. May 2023

drug device combination products regulatory quality requirements

Drug-Device Combination Products: Quality & Regulatory Requirements (US Edition)

6. June 2023

Medical device training with James Pink

Process Design, Scale-up and Technology Transfer for Medical Devices

Advanced Industrial Process and Unit Operations Scale-up

3. April 2023

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