1. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 1: DRUG SAFETY AND PHARMACOVIGILANCE
The Holiday Inn, Guildford, UK
Day One, Friday 24th February 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.15 Role of the Pharmaceutical Physician & QPPV in PV & Safety Alan Boyd
09.45 Classification of AEs & ADRs Cathy Baxter
10.30 Assessment of Evidence for Causality & Association Cathy Baxter
11.00 Coffee
11.15 Mechanisms of AEs, Predisposing Factors & QTc Testing Cathy Baxter
12.00 Dosage, Accumulation, Medication Errors, Interactions Cathy Baxter
& Safety Testing of Drug Dependence
12.30 Lunch
13.30 Collection of AEs in Clinical Trials, DSURs, Role of Sponsors Alan Boyd
& Investigators in Reporting, Regulatory Requirements & CIOMS
15.00 Tea
15.15 Spontaneous Reporting, Product Labelling, SmPC, PI, PIL Cathy Baxter
16.30 Off Label Use & Misuse Alan Boyd
17.00 Close
Day Two, Saturday 25th February 2012
09.00 Sources of Epidemiological & PV Information, Post-Authorisation Cathy Baxter
Safety Studies, Signal Detection, Interpretation & Management
10.30 Coffee
10.45 Benefit-Risk Assessment, Risk Management & Safety Specifications Alan Boyd
12.30 Lunch
13.30 Issue/Crisis Management, Dear HCP Communications & Alan Boyd
Product Withdrawal Procedures
15.15 Tea
15.30 Periodic Safety Update Reports Cathy Baxter
17.30 Close
13.5 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
© BaxterBoyd Limited 2012. All rights reserved.
2. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 2: NON-CLINICAL TESTING,
CLINICAL PHARMACOLOGY & THERAPEUTICS
The Holiday Inn, Guildford, UK
Day One, Friday 30th March 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.15 Non-Clinical Safety Testing (part 1) Christine Robinson
10.45 Coffee
11.00 Non-Clinical Safety Testing (part 2) & Safety Testing Christine Robinson
of Small Molecules vs. Biologicals
12.30 Lunch
13.30 Principles of Pharmacokinetics Alan Boyd
14.30 Factors Affecting Pharmacokinetics Alan Boyd
15.30 Tea
15.45 Drug Interactions Cathy Baxter
17.00 Population Pharmacokinetics Cathy Baxter
17.15 Close
Day Two, Saturday 31st March 2012
09.00 Exploratory Development & Phase 0 Trials TBC
Pharmacogenetics, Pharmacogenomics
09.45 First in Human Studies TBC
11.00 Coffee
11.15 Biomarkers, Clinical Endpoints, Surrogate Endpoints TBC
12.30 Lunch
13.30 Therapeutic Drug Monitoring & Compliance Cathy Baxter
15.30 Tea
15.45 Prescribing for Special Populations Alan Boyd
16.30 Overdose & Anaphylaxis Cathy Baxter
17.00 Close
13.25 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
© BaxterBoyd Limited 2012. All rights reserved.
3. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 3: MEDICINES REGULATION
The Holiday Inn, Guildford, UK
Day One, Friday 27th April 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.15 General Principles of Medicines Regulation, Cathy Baxter
ICH, GMP, GCP, GLP
10.30 Coffee
10.45 Clinical Trials Regulations – IND, CTA, EU Directives, Alan Boyd
Ethics & Ethics Committees, Fraud & Misconduct
12.30 Lunch
13.30 Licensing – MAA, Abridged Applications Cathy Baxter
14.30 Updating & Maintaining Licences Cathy Baxter
15.15 Tea
15.30 Common Technical Document & Overviews Alan Boyd
16.30 Orphan Drugs Alan Boyd
17.30 Close
Day Two, Saturday 28th April 2012
09.00 Product Information – SmPC, PI, PIL Alan Boyd
09.45 Drug Abuse, Dependence & Controlled Drugs Cathy Baxter
10.30 Coffee
10.45 Unlicensed Medicines & Early Access Programmes Cathy Baxter
11.30 Legal Reclassification (POM to OTC) Cathy Baxter
12.30 Lunch
13.30 Medicines Regulation in the US & Japan Cathy Baxter
15.00 Tea
15.15 ATMP Regulations, Medical Devices & IVDs Alan Boyd
16.15 Product Defects & Recall, Product Discontinuation Alan Boyd
17.00 Close
13.5 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
© BaxterBoyd Limited 2012. All rights reserved.
4. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 4: STATISTICS AND DATA MANAGEMENT
The Holiday Inn, Guildford, UK
Day One, Friday 25th May 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.15 Basic Inferential Statistics - Confidence Intervals, Mike Williams
P-Values & Hypothesis Testing, Type I & II Errors
10.30 Coffee
10.45 Study Design Issues – Risk Factors, Bias, Confounding, Mike Williams
Sample Size & Power
12.00 Workshop/Exercise Mike Williams
12.30 Lunch
13.30 Relationships & Comparisons – Correlation, Regression, Mike Williams
T-Tests & Chi-Squared
14.30 Clinical Trial Issues – Trial Design, Mike Williams
Efficacy & Safety Analysis, Relative Risk
15.30 Tea
15.45 Workshop/Exercise Mike Williams
16.30 Meta-analysis Mike Williams
17.00 Close
Day Two, Saturday 26st May 2012
09.00 Data Collection, Management & Standardisation Cathy Baxter
09.45 Interim Analysis & Role of the DSMB Alan Boyd
10.45 Coffee
11.00 Interpretation of Study Design, Analysis & Results Cathy Baxter
12.30 Lunch
13.30 SAQs & Essays: General Statistics & Survival Analysis Alan Boyd
15.15 Tea
15.30 Workshop: Statistics for the Clinical Paper Exam Cathy Baxter
17.00 Close
13 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
© BaxterBoyd Limited 2012. All rights reserved.
5. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 5: CLINICAL DEVELOPMENT & DISCOVERY MEDICINE
The Holiday Inn, Guildford, UK
Day One, Friday 29th June 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.15 Project Teams/Management, Planning & Budgets Alan Boyd
09.45 Types of Study, Study Design & Choice of Comparator Cathy Baxter
10.30 Coffee
10.45 Clinical Development Plans, Target Product Profile Alan Boyd
& Target Label, Clinical Development in Special Groups
11.45 Paediatric Clinical Development Cathy Baxter
12.45 Lunch
13.45 UK Clinical Trial Regulations, EU Directives/Guidance & ICH GCP Cathy Baxter
15.15 Tea
15.30 Ethics, Consent, Indemnity & Compensation, Study Follow-on Alan Boyd
16.15 Confidentiality & Data Protection Cathy Baxter
17.00 Close
Day Two, Saturday 30th June 2012
09.00 Adverse Events in Clinical Studies Cathy Baxter
10.30 Coffee
10.45 Study Conduct, Documentation, Investigator Brochure Alan Boyd
& Contractual Arrangements
11.30 Workshop: Developing a Product Alan Boyd
12.30 Lunch
13.30 Clinical Trial Reports, Annual Reports & CTD Summaries Alan Boyd
15.00 Tea
15.15 Study Drugs, Manufacturing, Labelling & Presentation Cathy Baxter
16.00 Discovery of New Medicines Alan Boyd
17.00 Close
13 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
© BaxterBoyd Limited 2012. All rights reserved.
6. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 6: HEALTHCARE MARKETPLACE
The Holiday Inn, Guildford, UK
Day One, Friday 27th July 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.15 Legal & Regulatory Framework for Cathy Baxter
Medicines Promotion
10.45 Coffee
11.00 Pricing & Price Negotiations Alan Boyd
11.45 Product Liability & Compensation Alan Boyd
12.30 Lunch
13.30 Marketing Workshop: Principles & Practice of Marketing, Cathy Baxter
Product Launch, Support & Life-Cycle Management
15.15 Tea
15.30 Marketing Workshop (continued) Cathy Baxter
17.00 Close
Day Two, Saturday 28th July 2012
09.00 Principles of Health Economics Cathy Baxter
10.00 Quality of Life & Pharmacoepidemiology Alan Boyd
11.00 Coffee
11.15 Measurement of Healthcare, Government Policy, Cathy Baxter
Third-Party Reimbursement & Formularies
12.30 Lunch
13.30 In-Licensing & Co-Marketing Alan Boyd
15.30 Tea
15.45 Intellectual Property, Parallel Imports & Legal Issues Cathy Baxter
16.30 Medicines Counterfeiting Cathy Baxter
17.00 Close
13 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
© BaxterBoyd Limited 2012. All rights reserved.
7. Diploma in Pharmaceutical Medicine
Training Programme 2012
A new approach to preparation for the Diploma in Pharmaceutical Medicine
Module 7: EXAM TECHNIQUE & MOCK EXAM
The Holiday Inn, Guildford, UK
Day One, Saturday 15th September 2012
08.30 Arrivals & Registration
09.00 Introduction & Course Overview Alan Boyd/Cathy Baxter
09.30 Past Papers & Exam Analysis Cathy Baxter
10.00 Coaching for the SAQs Alan Boyd
11.00 Coffee
11.15 Practice SAQs – Group Workshops Alan Boyd
12.30 Lunch
13.30 Practice SAQs – Workshop Feedback Alan Boyd
14.30 Coaching for the Critical Appraisal Paper Cathy Baxter
15.45 Tea
16.00 Practice Critical Appraisal Papers – Group/Individual Workshops Alan Boyd
17.30 Close
Day Two, Sunday 16th September 2012
09.00 Coaching for the MCQs Cathy Baxter
10.30 Coffee
10.45 Practice MCQs Cathy Baxter
12.30 Lunch
13.30 Mock Exam: MCQs, SAQs & Critical Appraisal Paper Alan Boyd/Cathy Baxter
16.45 Q&A & Final Thoughts Alan Boyd/Cathy Baxter
17.00 Close
13.75 CPD points have been awarded by the Faculty of Pharmaceutical Medicine
To register for this event or for further information, please contact BaxterBoyd on
+44 (0)1270 270010 or via e-mail enquiries@baxterboyd.com
As this module is extremely popular and places may be limited please book early to secure a place
© BaxterBoyd Limited 2012. All rights reserved.
