This document lists various medical device, regulatory affairs, biopharmaceutical, clinical, manufacturing, R&D, business strategy, and veterinary medicine courses provided by MDTi Global and PTI Global. It provides the course titles, dates, and locations for over 50 different courses on topics ranging from regulatory compliance to clinical research to biomanufacturing. Most courses will be held in London in 2016, with some also in Prague, Amsterdam, and online.

1. Medical Device Courses
Course Dates Location
Managing the Transition to the New IVD Regulation
http://www.mdti-global.co.uk/IVDRegulation
9-10 February 2016
11-12 July 2016
2-3 November 2016
All courses will be held in London.
Introduction to Regulatory Affairs for IVDs
http://www.mdti-global.co.uk/introIVD
3-4 March 2016
24-25 October 2016
Advanced Regulatory Affairs for Medical Devices
http://www.mdti-global.co.uk/advmeddev
3-4 March 2016
9-10 June 2016
29-30 September 2016
Understanding Clinical Evaluations, Investigations and Post Market
Clinical Studies
http://www.mdti-global.co.uk/ClinicalEvaluationInvestigation
6-7 April 2016
7-8 November 2016
Marketing Authorisation in the CIS for Medical Devices
http://www.mdti-global.co.uk/cismeddev
21-22 April 2016
1-2 December 2016
Regulatory Affairs in Latin America for Medical Devices
http://www.mdti-global.co.uk/latinmeddev
10-11 March 2016
15-16 December 2016
Medical Device School
http://www.mdti-global.co.uk/meddevss
12-14 April 2016
7-9 November 2016
Introduction to Regulatory Affairs for Medical Devices
http://www.mdti-global.co.uk/rameddev
7-8 June 2016
19-20 September 2016
Successful Medical Device and IVD PMS and Vigilance Reporting
http://www.mdti-global.co.uk/pms
21-22 June 2016
4-5 October 2016
2016 Training Courses
These dates and locations are subject to change.

2. Regulatory Affairs Courses
Course Dates Location
eCTD Submissions
www.pti-global.co.uk/eCTD
20-21 January 2016
11-12 May 2016
28-29 September 2016
All courses will be held in
London
Understanding and Preparing the Quality and Pharmaceutical Module of the Global
CTD Dossier
www.pti-global.co.uk/dossier
27-29 January 2016
9-11 May 2016
19-21 October 2016
Advanced European Regulatory Affairs
www.pti-global.co.uk/advreg
9-11 February 2016
1-3 June 2016
12-14 October 2016
Regulatory Information Management and IDMP
www.pti-global.co.uk/RIMandIDMP
9-10 February 2016
9-10 June 2016
10-11 November 2016
Filing Variations
www.pti-global.co.uk/filingvariations
10-11 March 2016
8-9 June 2016
10-11 September 2016
London
Prague
Prague
Regulatory Affairs for Clinical Trials
www.pti-global.co.uk/raclinical
4-5 April 2016
19-20 September 2016
Fundamentals to European Regulatory Affairs 13-15 April 2016
Practical Guidance for Medical Device Audits and Inspections
http://www.mdti-global.co.uk/MedDevAudits
18-19 July 2016
5-12 December 2016
Conducting Medical Device Trials in the EU
http://www.pti-global.co.uk/mdtrialswc
Online course At your own desk

3. www.pti-global.co.uk/euregaffairs
26-28 July 2016
22-24 November 2016
EU and US Requirements for Pharmaceutical Labelling and Package Leaflets
www.pti-global.co.uk/EUlabelling
21-23 June 2016
Intermediate Pharmacovigilance Training
www.pti-global.co.uk/adr
11-12 July 2016
Gaining Marketing Authorisation in the CIS for Pharmaceutical and Biotech
www.pti-global.co.uk/cis
17-18 August 2016
5-6 December 2016
US-FDA Drug Submission Procedures
www.pti-global.co.uk/usafda
21-22 September 2016
Regulatory Affairs Strategies
www.pti-global.co.uk/rastrategies
22-23 September 2016
China: Regulatory Affairs in Pharmaceuticals
www.pti-global.co.uk/regaffchina
28-29 September 2016
Regulatory Development Strategies for Generics
www.pti-global.co.uk/genericscourse
4-5 October 2016
Introduction to Regulatory Affairs in the MENA Region
www.pti-global.co.uk/regaffairsmena
6-7 October 2016
Regulatory Affairs in Latin America
www.pti-global.co.uk/latin
14-15 March 2016
13-14 December 2016
Pharmaceutical Regulatory Affairs in the EU and US
http://www.pti-global.co.uk/regaffairswc
Online learning course At your own desk
A Practical guide to Pharmacovigilance
http://www.pti-global.co.uk/pharmacowc

4. Biopharmaceutical Courses
Courses Dates Location
Analysing Bioassays and Immunoassays
http://www.pti-global.co.uk/assay
23-24 February 2016
21-22 June 2016
3-4 November 2016
London
Amsterdam
London
Bioprocess Characterisation, Qualification and Validation
http://www.pti-global.co.uk/bioprocess
4-5 April 2016
14-15 September 2016
London
London
Introductory CMC Analytical, Comparability and Stability Testing and Lab Practices for
Biotech and Biosimilar Products
http://www.pti-global.co.uk/stabilitybiotech
19-20 May 2016
13-14 October 2016
London
London
Advanced CMC Analytical, Comparability and Stability Testing and Lab Practices for
Biotech and Biosimilar Products
http://www.pti-global.co.uk/advancedcmc
23-24 May 2016
17-18 October 2015
London
London
Comparability for Biologics
http://www.pti-global.co.uk/comparabilitypti
18-19 July 2016
30 November -1 December 2016
London
Dublin
A Practical Guide to Biopharmaceutical Manufacturing
http://www.pti-global.co.uk/event/biomanwc
Online learning course At you own desk
Clinical Courses
Courses Dates Location
Effectively Managing Vendor Oversight
http://www.pti-global.co.uk/oversight
25-26 February 2016
6-7 October 2016
All courses will be held in
London
Clinical Research Project Management
http://www.pti-global.co.uk/crpm
9-11 March 2016
19-21 November 2016
CRO Contracts 24-25 October 2016

5. http://www.pti-global.co.uk/event/cro
Risk Based Monitoring for Targeted SDV
http://www.pti-global.co.uk/event/riskmonitoring
26-27 October 2016
Budget Management for Clinical Trials
http://www.pti-global.co.uk/event/budgetmanagement
1-2 December 2016
How to Survive a Competent Authority Inspection of a Clinical Trial
http://www.pti-global.co.uk/event/CTinspection
Online learning course At your own desk
Manufacturing Courses
Courses Dates Location
Bioavailability and Bioequivalence
http://www.pti-global.co.uk/bioavailability
6-7 April 2016
15-16 December 2016
Prague*
London
Dissolution Testing
http://www.pti-global.co.uk/dissolution
11-12 July 2016
21-22 November 2016
London
London
Stability Testing in Pharmaceutical Products
http://www.pti-global.co.uk/stability
28-29 November 2016 London
Good Manufacturing Practices
http://www.pti-global.co.uk/GMP
Online learning course At your own desk
R&D Courses
Courses Dates Location
Practical Solutions for Establishing In-Vitro In-Vivo Correlation
http://www.pti-global.co.uk/ivivc
4-5 April 2016
13-14 December 2016
Prague
London
Introduction to Pharmacokinetics for the Non-Specialist
http://www.pti-global.co.uk/pharmaco
19-20 April 2016
15-16 November 2016
All courses will be held in
London

6. Genotoxic Impurities – Strategies for Identification and Control
http://www.pti-global.co.uk/genotoxic
24-25 May 2016
12-13 September 2016
Introduction to Toxicology for the Non-Specialist
http://www.pti-global.co.uk/event/Toxicology
7-8 June 2016
11-12 October 2016
Managing Non-clinical Outsourcing and Study Monitoring
http://www.pti-global.co.uk/NCO
10-11 May 2016
How Drugs are Developed
http://www.pti-global.co.uk/hdadwc
Online learning course At your own desk
Business Strategy Courses
Courses Dates Location
Pharma and Biopharm Executive mini MBA
http://www.pti-global.co.uk/pharmamba
14-18 November 2016 London
An Introduction to Pharmacoeconomics
http://www.pti-global.co.uk/pharmacoeconomics
Online learning course At your own desk
Pharmaceutical Licensing
http://www.pti-global.co.uk/licensingwc
Veterinary Medicine Courses
Courses Dates Location
Regulatory Affairs for Veterinary Medicine
http://www.pti-global.co.uk/vetmed
24-25 October 2016 London
If you’re interested in any of the above courses and would like more information, please contact Frederique
Thomas: frederique.thomas@informa.com